HIV, Gonorrhea, Chlamydia
Conditions
Brief summary
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM. The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta. Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys. The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes. In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.
Interventions
BEHAVIORALKeep It Up!
BEHAVIORALHIV Knowledge Control
Sponsors
National Institute on Drug Abuse (NIDA)
Emory University
Hunter College of City University of New York
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Birth male who identifies as male and reports sexual contact with another male * Received an HIV negative test result from a participating clinic/recruitment site * Unprotected anal sex with another male in the last 6 months * Ability to read English at 8th grade level
Exclusion criteria
* HIV positive * Female or Transgender * No email address for contact * Currently in a monogamous relationship lasting longer than 6 months * Participated in previous versions of KIU!
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | Baseline, 3 Months | Change in self-report of condomless anal sex acts at three months. |
| Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | 12 months | The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months. |
| Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Baseline | The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline. |
| Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | Baseline, 12 Months | Change in self-report of condomless anal sex acts at twelve months. |
| Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | Baseline, 6 Months | Change in self-report of condomless anal sex acts at six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Condom Errors at Baseline and 6 Months | Baseline, 6 Months | The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors |
| Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months | Baseline, 6 Months | The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk. |
| Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline, 6 Months | At six months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4 |
| Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline, 6 Months | The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing). |
| Mean Score of Condom Errors at Baseline and 12 Months | Baseline, 12 Months | The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors. |
| Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months | Baseline, 12 Months | The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk. |
| Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline, 12 Months | At twelve months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4 |
| Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline, 12 Months | The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing). |
| Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months | Baseline, 12 Months | The change in effect that HIV testing has on health beliefs (for example, I cannot get HIV) and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability |
| Mean Score of Condom Errors at Baseline and 3 Months | Baseline, 3 Months | The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors. |
| Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months | Baseline, 3 Months | The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk. |
| Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline, 3 Months | At three months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4 |
| Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline, 3 Months | The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing). |
| Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months | Baseline, 12 Month | The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | 6 Months | The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline. |
| Level of Privacy | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) | Log of the levels of privacy of the locations where participants completed intervention. |
| Participant Experiences of Harm at 6 Month Follow-up | 6 Months | Log of any negative experiences or harm experienced by participant at six months. |
| Participant Experiences of Harm at 3 Month Follow-up | 3 Months | Log of any negative experiences or harm experienced by participant at three months. |
| Participant Location | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) | Log of where participants completed the intervention sessions (participants can select multiple locations). |
| Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | 3 Months | The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline. |
| Participant Experiences of Harm at 12 Month Follow-up | 12 Months | Log of any negative experiences or harm experienced by participant at twelve months. |
| Participant Rating of Intervention Acceptability and Tolerability | Immediately following completion of intervention (up to 3 weeks after intervention is started by participant) | Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability. |
Countries
United States
Participant flow
Recruitment details
From May 2013 to December 2015, 901 participants were recruited and enrolled from (1) community-based HIV testing organizations in Atlanta, Chicago, and New York; (2) local health department clinics in Chicago; (3) street outreach in Atlanta, Chicago, and New York; and (4) local and national advertising.
Pre-assignment details
Participants were randomized after completing a baseline assessment and STI testing.
Participants by arm
| Arm | Count |
|---|---|
| Keep It Up! Intervention The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.
Keep It Up! | 445 |
| HIV Knowledge Control The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).
HIV Knowledge Control | 456 |
| Total | 901 |
Baseline characteristics
| Characteristic | Total | HIV Knowledge Control | Keep It Up! Intervention |
|---|---|---|---|
| Age, Continuous | 24.21 years STANDARD_DEVIATION 2.95 | 24.15 years STANDARD_DEVIATION 2.89 | 24.27 years STANDARD_DEVIATION 3.02 |
| Age, Customized 18 - 24 | 477 Participants | 244 Participants | 233 Participants |
| Age, Customized 25 - 29 | 423 Participants | 212 Participants | 211 Participants |
| Condomless Anal Sex | 3.9 condomless anal sex acts STANDARD_DEVIATION 9.9 | 3.4 condomless anal sex acts STANDARD_DEVIATION 6.7 | 4.3 condomless anal sex acts STANDARD_DEVIATION 13.1 |
| Education College Education | 418 Participants | 215 Participants | 203 Participants |
| Education Graduate Degree | 118 Participants | 62 Participants | 56 Participants |
| Education High School Graduate/GED | 95 Participants | 35 Participants | 60 Participants |
| Education Junior High School | 1 Participants | 1 Participants | 0 Participants |
| Education Partial College (at Least One Year) | 252 Participants | 136 Participants | 116 Participants |
| Education Partial High School | 17 Participants | 7 Participants | 10 Participants |
| Employment Full Time | 451 Participants | 228 Participants | 223 Participants |
| Employment Part Time | 250 Participants | 135 Participants | 115 Participants |
| Race/Ethnicity, Customized Asian | 37 Participants | 22 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 219 Participants | 113 Participants | 106 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 260 Participants | 125 Participants | 135 Participants |
| Race/Ethnicity, Customized More than one race | 32 Participants | 17 Participants | 15 Participants |
| Race/Ethnicity, Customized Native American | 5 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 18 Participants | 10 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 330 Participants | 165 Participants | 165 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 901 Participants | 456 Participants | 445 Participants |
| Sexually Transmitted Infections Any STI | 132 Participants | 50 Participants | 82 Participants |
| Sexually Transmitted Infections Rectal Chlamydia | 77 Participants | 30 Participants | 47 Participants |
| Sexually Transmitted Infections Rectal Gonorrhea | 45 Participants | 16 Participants | 29 Participants |
| Sexually Transmitted Infections Urethral Chlamydia | 22 Participants | 7 Participants | 15 Participants |
| Sexually Transmitted Infections Urethral Gonorrhea | 7 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 445 | 0 / 456 |
| other Total, other adverse events | 0 / 445 | 0 / 456 |
| serious Total, serious adverse events | 11 / 445 | 13 / 456 |
Outcome results
Primary
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.
Time frame: 12 months
Population: Enrolled participants who returned STI test kits for analysis at 12 month follow-up.~Denominator varies by testing site and study arm: urethral (control - 374; intervention - 359) rectal (control - 374; intervention - 356)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Urethral Gonorrhea | 1 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Rectal Gonorrhea | 13 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Rectal Chlamydia | 22 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Any STI | 31 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Urethral Chlamydia | 4 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Any STI | 54 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Urethral Chlamydia | 7 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Urethral Gonorrhea | 3 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Rectal Chlamydia | 38 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months | Rectal Gonorrhea | 15 Participants |
p-value: 0.0195% CI: [0.38, 0.95]Z-test
Primary
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Time frame: Baseline
Population: Enrolled participants who returned STI test kits for analysis at baseline. Denominator varies by testing site and study arm: urethral (control - 452; intervention - 441) rectal (control - 449; intervention - 442)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Urethral Gonorrhea | 3 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Rectal Gonorrhea | 29 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Rectal Chlamydia | 47 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Any STI | 82 Participants |
| Keep It Up! Intervention | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Urethral Chlamydia | 15 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Any STI | 50 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Urethral Chlamydia | 7 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Urethral Gonorrhea | 4 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Rectal Chlamydia | 30 Participants |
| HIV Knowledge Control | Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline | Rectal Gonorrhea | 16 Participants |
Primary
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
Change in self-report of condomless anal sex acts at twelve months.
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 12 month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | Baseline | 304 Participants |
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | 12 Month Follow-up | 136 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | 12 Month Follow-up | 173 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months | Baseline | 312 Participants |
p-value: 0.0495% CI: [0.7, 0.99]Regression, Logistic
Primary
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Change in self-report of condomless anal sex acts at three months.
Time frame: Baseline, 3 Months
Population: Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 3 month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | Baseline | 304 Participants |
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | 3 Month Follow-up | 148 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | Baseline | 312 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months | 3 Month Follow-up | 184 Participants |
p-value: 0.295% CI: [0.76, 1.06]Regression, Logistic
Primary
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
Change in self-report of condomless anal sex acts at six months.
Time frame: Baseline, 6 Months
Population: Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 6 month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | Baseline | 304 Participants |
| Keep It Up! Intervention | Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | 6 Month Follow-up | 133 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | Baseline | 312 Participants |
| HIV Knowledge Control | Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months | 6 Month Follow-up | 156 Participants |
p-value: 0.695% CI: [0.8, 1.14]Regression, Logistic
Secondary
Mean Score of Condom Errors at Baseline and 12 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on their condom errors at baseline and 12 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 12 Months | Baseline | 4.31 units on a scale | Standard Deviation 2.31 |
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 12 Months | 12 Month Follow-up | 3.30 units on a scale | Standard Deviation 2.49 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 12 Months | Baseline | 4.02 units on a scale | Standard Deviation 2.23 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 12 Months | 12 Month Follow-up | 3.16 units on a scale | Standard Deviation 2.24 |
p-value: 0.862Regression, Linear
Secondary
Mean Score of Condom Errors at Baseline and 3 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Time frame: Baseline, 3 Months
Population: Enrolled participants who completed assessments on condom errors at baseline and 3 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 3 Months | Baseline | 4.28 units on a scale | Standard Deviation 2.16 |
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 3 Months | 3 Month Follow-up | 3.23 units on a scale | Standard Deviation 2.27 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 3 Months | Baseline | 4.05 units on a scale | Standard Deviation 2.12 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 3 Months | 3 Month Follow-up | 3.45 units on a scale | Standard Deviation 2.09 |
p-value: 0.15Regression, Linear
Secondary
Mean Score of Condom Errors at Baseline and 6 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors
Time frame: Baseline, 6 Months
Population: Enrolled participants who completed assessments on condom errors at baseline and 6 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 6 Months | Baseline | 4.29 units on a scale | Standard Deviation 2.14 |
| Keep It Up! Intervention | Mean Score of Condom Errors at Baseline and 6 Months | 6 Month Follow-up | 3.09 units on a scale | Standard Deviation 2.2 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 6 Months | Baseline | 3.96 units on a scale | Standard Deviation 2.13 |
| HIV Knowledge Control | Mean Score of Condom Errors at Baseline and 6 Months | 6 Month Follow-up | 3.12 units on a scale | Standard Deviation 2.35 |
p-value: 0.173Regression, Linear
Secondary
Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months
The change in effect that HIV testing has on health beliefs (for example, I cannot get HIV) and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on HIV invulnerability at baseline and 12 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months | Baseline | 1.92 units on a scale | Standard Deviation 0.75 |
| Keep It Up! Intervention | Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months | 12 Month Follow-up | 2.05 units on a scale | Standard Deviation 0.78 |
| HIV Knowledge Control | Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months | Baseline | 1.84 units on a scale | Standard Deviation 0.74 |
| HIV Knowledge Control | Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months | 12 Month Follow-up | 1.95 units on a scale | Standard Deviation 0.74 |
p-value: 0.719Regression, Linear
Secondary
Mean Score of Health Protective Communication Skills at Baseline and 12 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on health protective communication (HPC) Relationship \& condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points Higher score = less HPC skills; range 1-4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC Relationship Maintenance | 1.32 units on a scale | Standard Deviation 0.79 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC Relationship Maintenance | 1.65 units on a scale | Standard Deviation 0.88 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC Condom Use | 1.32 units on a scale | Standard Deviation 0.83 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC Condom Use | 1.12 units on a scale | Standard Deviation 0.95 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC HIV Testing | 0.57 units on a scale | Standard Deviation 0.68 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC HIV Testing | 0.64 units on a scale | Standard Deviation 0.73 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC HIV Testing | 0.48 units on a scale | Standard Deviation 0.65 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC Relationship Maintenance | 1.31 units on a scale | Standard Deviation 0.8 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC Condom Use | 0.96 units on a scale | Standard Deviation 0.89 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC Relationship Maintenance | 1.45 units on a scale | Standard Deviation 0.87 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | 12 Month Follow-up - HPC HIV Testing | 0.56 units on a scale | Standard Deviation 0.68 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 12 Months | Baseline - HPC Condom Use | 1.09 units on a scale | Standard Deviation 0.85 |
Comparison: Analysis for Relationship Maintenance itemsp-value: 0.036Regression, Linear
Comparison: Analysis for Condom Use itemsp-value: 0.837Regression, Linear
Comparison: Analysis for HIV Testing itemsp-value: 0.953Regression, Linear
Secondary
Mean Score of Health Protective Communication Skills at Baseline and 3 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time frame: Baseline, 3 Months
Population: Enrolled participants who completed assessments on health protective communication (HPC) Relationship \& condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC Relationship Maintenance | 1.34 units on a scale | Standard Deviation 0.75 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC Relationship Maintenance | 1.46 units on a scale | Standard Deviation 0.89 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC Condom Use | 1.32 units on a scale | Standard Deviation 0.86 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC Condom Use | 1.38 units on a scale | Standard Deviation 0.92 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC HIV Testing | 0.76 units on a scale | Standard Deviation 0.75 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC HIV Testing | 0.71 units on a scale | Standard Deviation 0.73 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC HIV Testing | 0.43 units on a scale | Standard Deviation 0.63 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC Relationship Maintenance | 1.36 units on a scale | Standard Deviation 0.8 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC Condom Use | 1.22 units on a scale | Standard Deviation 0.97 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC Relationship Maintenance | 1.37 units on a scale | Standard Deviation 0.83 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | 3 Month Follow-up - HPC HIV Testing | 0.61 units on a scale | Standard Deviation 0.63 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 3 Months | Baseline - HPC Condom Use | 1.10 units on a scale | Standard Deviation 0.81 |
Comparison: Analysis for Relationship Maintenance itemsp-value: 0.067Regression, Linear
Comparison: Analysis for Condom Use itemsp-value: 0.135Regression, Linear
Comparison: Analysis for HIV Testing itemsp-value: 0.025Regression, Linear
Secondary
Mean Score of Health Protective Communication Skills at Baseline and 6 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Time frame: Baseline, 6 Months
Population: Enrolled participants who completed assessments on health protective communication (HPC) Relationship \& condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC Relationship Maintenance | 1.36 units on a scale | Standard Deviation 0.75 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC Relationship Maintenance | 1.65 units on a scale | Standard Deviation 0.91 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC Condom Use | 1.35 units on a scale | Standard Deviation 0.85 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC Condom Use | 1.25 units on a scale | Standard Deviation 0.95 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC HIV Testing | 0.61 units on a scale | Standard Deviation 0.68 |
| Keep It Up! Intervention | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC HIV Testing | 0.74 units on a scale | Standard Deviation 0.88 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC HIV Testing | 0.48 units on a scale | Standard Deviation 0.7 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC Relationship Maintenance | 1.35 units on a scale | Standard Deviation 0.78 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC Condom Use | 1.10 units on a scale | Standard Deviation 0.96 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC Relationship Maintenance | 1.39 units on a scale | Standard Deviation 0.83 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | 6 Month Follow-up - HPC HIV Testing | 0.69 units on a scale | Standard Deviation 0.8 |
| HIV Knowledge Control | Mean Score of Health Protective Communication Skills at Baseline and 6 Months | Baseline - HPC Condom Use | 1.06 units on a scale | Standard Deviation 0.78 |
Comparison: Analysis for Relationship Maintenance itemsp-value: 0.001Regression, Linear
Comparison: Analysis for Condom Use itemsp-value: 0.067Regression, Linear
Comparison: Analysis for HIV Testing itemsp-value: 0.637Regression, Linear
Secondary
Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months
At twelve months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on motivation \& behavioral skills at baseline and 12 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Motivational Self-Rating | 3.13 units on a scale | Standard Deviation 0.8 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Motivational Self-Rating | 2.93 units on a scale | Standard Deviation 0.94 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Social Norms | 4.32 units on a scale | Standard Deviation 0.58 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Social Norms | 4.24 units on a scale | Standard Deviation 0.65 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Behavioral Skills | 1.35 units on a scale | Standard Deviation 0.39 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Behavioral Skills | 1.38 units on a scale | Standard Deviation 0.47 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Behavioral Skills | 1.39 units on a scale | Standard Deviation 0.38 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Motivational Self-Rating | 3.02 units on a scale | Standard Deviation 0.87 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Social Norms | 4.23 units on a scale | Standard Deviation 0.67 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Motivational Self-Rating | 2.97 units on a scale | Standard Deviation 0.99 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | 12 Month Follow-up - Behavioral Skills | 1.39 units on a scale | Standard Deviation 0.46 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months | Baseline - Social Norms | 4.34 units on a scale | Standard Deviation 0.53 |
Comparison: Analysis for Motivation itemsp-value: 0.043Regression, Linear
Comparison: Analysis for Social Norm itemsp-value: 0.617Regression, Linear
Comparison: Analysis for Behavioral Skills itemsp-value: 0.57Regression, Linear
Secondary
Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months
At three months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time frame: Baseline, 3 Months
Population: Enrolled participants who completed assessments on motivation \& behavioral skills at baseline and 3 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Motivational Self-Rating | 3.11 units on a scale | Standard Deviation 0.91 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Motivational Self-Rating | 3.11 units on a scale | Standard Deviation 0.8 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Social Norms | 4.36 units on a scale | Standard Deviation 0.54 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Social Norms | 4.37 units on a scale | Standard Deviation 0.62 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Behavioral Skills | 1.36 units on a scale | Standard Deviation 0.39 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Behavioral Skills | 1.28 units on a scale | Standard Deviation 0.35 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Behavioral Skills | 1.39 units on a scale | Standard Deviation 0.39 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Social Norms | 4.32 units on a scale | Standard Deviation 0.62 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Motivational Self-Rating | 3.02 units on a scale | Standard Deviation 0.87 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Motivational Self-Rating | 3.03 units on a scale | Standard Deviation 0.92 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | 3 Month Follow-up - Behavioral Skills | 1.38 units on a scale | Standard Deviation 0.42 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months | Baseline - Social Norms | 4.33 units on a scale | Standard Deviation 0.53 |
Comparison: Analysis for Motivation itemsp-value: 0.919Regression, Linear
Comparison: Analysis for Social Norms itemsp-value: 0.493Regression, Linear
Comparison: Analysis for Behavioral Skills itemsp-value: 0.002Regression, Linear
Secondary
Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months
At six months, the change in: * Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer) * Social Norms (for example, partners, friends, or family members opinions about condom use) * Behavioral Skills (for example, negotiating condom use) Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Time frame: Baseline, 6 Months
Population: Enrolled participants who completed assessments on motivation \& behavioral skills at baseline and 6 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Motivational Self-Rating | 3.13 units on a scale | Standard Deviation 0.8 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Motivational Self-Rating | 3.12 units on a scale | Standard Deviation 0.9 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Social Norms | 4.35 units on a scale | Standard Deviation 0.54 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Social Norms | 4.31 units on a scale | Standard Deviation 0.66 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Behavioral Skills | 1.36 units on a scale | Standard Deviation 0.39 |
| Keep It Up! Intervention | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Behavioral Skills | 1.30 units on a scale | Standard Deviation 0.4 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Behavioral Skills | 1.39 units on a scale | Standard Deviation 0.38 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Motivational Self-Rating | 3.03 units on a scale | Standard Deviation 0.85 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Social Norms | 4.27 units on a scale | Standard Deviation 0.72 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Motivational Self-Rating | 3.04 units on a scale | Standard Deviation 0.93 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | 6 Month Follow-up - Behavioral Skills | 1.37 units on a scale | Standard Deviation 0.41 |
| HIV Knowledge Control | Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months | Baseline - Social Norms | 4.34 units on a scale | Standard Deviation 0.53 |
Comparison: Analysis for motivation itemsp-value: 0.861Regression, Linear
Comparison: Analysis for social norms itemsp-value: 0.628Regression, Linear
Comparison: Analysis for behavioral skills itemsp-value: 0.151Regression, Linear
Secondary
Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.
Time frame: Baseline, 12 Month
Population: Enrolled participants who completed assessments on drug use before sex at baseline and 12 month.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months | 12 Month Follow-up | 92 Participants |
| Keep It Up! Intervention | Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months | Baseline | 100 Participants |
| HIV Knowledge Control | Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months | Baseline | 108 Participants |
| HIV Knowledge Control | Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months | 12 Month Follow-up | 84 Participants |
p-value: 0.138Regression, Logistic
Secondary
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months
The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time frame: Baseline, 12 Months
Population: Enrolled participants who completed assessments on their HIV Knowledge at baseline and 12 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months | Baseline | 85.02 percentage of correct responses | Standard Deviation 13.67 |
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months | 12 Month Follow-up | 88.46 percentage of correct responses | Standard Deviation 13.15 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months | Baseline | 86.76 percentage of correct responses | Standard Deviation 10.88 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months | 12 Month Follow-up | 89.94 percentage of correct responses | Standard Deviation 10.34 |
p-value: 0.762Regression, Linear
Secondary
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months
The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time frame: Baseline, 3 Months
Population: Enrolled participants who completed assessments on HIV knowledge at baseline and 3 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months | Baseline | 85.93 percentage of correct responses | Standard Deviation 13 |
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months | 3 Month Follow-up | 89.11 percentage of correct responses | Standard Deviation 11.22 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months | Baseline | 86.41 percentage of correct responses | Standard Deviation 11.64 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months | 3 Month Follow-up | 88.68 percentage of correct responses | Standard Deviation 11.8 |
p-value: 0.374Regression, Linear
Secondary
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months
The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Time frame: Baseline, 6 Months
Population: Enrolled participants who completed assessments on HIV Knowledge at baseline and 6 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months | Baseline | 85.78 percentage of correct responses | Standard Deviation 13.21 |
| Keep It Up! Intervention | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months | 6 Month Follow-up | 88.96 percentage of correct responses | Standard Deviation 12.52 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months | Baseline | 86.69 percentage of correct responses | Standard Deviation 11.59 |
| HIV Knowledge Control | Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months | 6 Month Follow-up | 89.25 percentage of correct responses | Standard Deviation 12.31 |
p-value: 0.567Regression, Linear
Other Pre-specified
Level of Privacy
Log of the levels of privacy of the locations where participants completed intervention.
Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Population: Participants who reported information about the locations where they completed the intervention sessions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Level of Privacy | Not Private At All | 14 Participants |
| Keep It Up! Intervention | Level of Privacy | Somewhat Private | 74 Participants |
| Keep It Up! Intervention | Level of Privacy | Moderately Private | 81 Participants |
| Keep It Up! Intervention | Level of Privacy | Completely Private | 204 Participants |
| HIV Knowledge Control | Level of Privacy | Completely Private | 199 Participants |
| HIV Knowledge Control | Level of Privacy | Not Private At All | 28 Participants |
| HIV Knowledge Control | Level of Privacy | Moderately Private | 106 Participants |
| HIV Knowledge Control | Level of Privacy | Somewhat Private | 100 Participants |
Other Pre-specified
Occurrence of Sexually Transmitted Infections (STIs) at 3 Months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.
Time frame: 3 Months
Population: Participants who were positive for an STI at baseline, were sent a follow-up test kit at 3 Month Follow-up, and tested positive again.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Urethral Gonorrhea | 0 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Rectal Gonorrhea | 6 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Rectal Chlamydia | 12 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Any STI | 9 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Urethral Chlamydia | 1 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Any STI | 5 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Urethral Chlamydia | 1 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Urethral Gonorrhea | 0 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Rectal Chlamydia | 11 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 3 Months | Rectal Gonorrhea | 4 Participants |
Other Pre-specified
Occurrence of Sexually Transmitted Infections (STIs) at 6 Months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.
Time frame: 6 Months
Population: Participants who were positive for an STI at baseline, were sent a follow-up test kit at 6 Month Follow-up, and tested positive again.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Urethral Gonorrhea | 0 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Rectal Gonorrhea | 2 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Rectal Chlamydia | 7 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Any STI | 9 Participants |
| Keep It Up! Intervention | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Urethral Chlamydia | 0 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Any STI | 5 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Urethral Chlamydia | 0 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Urethral Gonorrhea | 0 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Rectal Chlamydia | 5 Participants |
| HIV Knowledge Control | Occurrence of Sexually Transmitted Infections (STIs) at 6 Months | Rectal Gonorrhea | 0 Participants |
Other Pre-specified
Participant Experiences of Harm at 12 Month Follow-up
Log of any negative experiences or harm experienced by participant at twelve months.
Time frame: 12 Months
Population: Number of participants who reported negative health experiences at 12 Month Follow-up as a result of participating in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Keep It Up! Intervention | Participant Experiences of Harm at 12 Month Follow-up | 0 Participants |
| HIV Knowledge Control | Participant Experiences of Harm at 12 Month Follow-up | 0 Participants |
Other Pre-specified
Participant Experiences of Harm at 3 Month Follow-up
Log of any negative experiences or harm experienced by participant at three months.
Time frame: 3 Months
Population: Number of participants who reported negative health experiences at 3 Month Follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Keep It Up! Intervention | Participant Experiences of Harm at 3 Month Follow-up | 0 Participants |
| HIV Knowledge Control | Participant Experiences of Harm at 3 Month Follow-up | 0 Participants |
Other Pre-specified
Participant Experiences of Harm at 6 Month Follow-up
Log of any negative experiences or harm experienced by participant at six months.
Time frame: 6 Months
Population: Number of participants who reported negative health experiences at 6 Month Follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Keep It Up! Intervention | Participant Experiences of Harm at 6 Month Follow-up | 0 Participants |
| HIV Knowledge Control | Participant Experiences of Harm at 6 Month Follow-up | 0 Participants |
Other Pre-specified
Participant Location
Log of where participants completed the intervention sessions (participants can select multiple locations).
Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Population: Participants who reported information about the locations where they completed the intervention sessions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Keep It Up! Intervention | Participant Location | Coffee Shop | 21 Participants |
| Keep It Up! Intervention | Participant Location | Library | 25 Participants |
| Keep It Up! Intervention | Participant Location | At Home, In Bedroom | 231 Participants |
| Keep It Up! Intervention | Participant Location | Friend's House | 32 Participants |
| Keep It Up! Intervention | Participant Location | Community Center | 16 Participants |
| Keep It Up! Intervention | Participant Location | Other | 69 Participants |
| Keep It Up! Intervention | Participant Location | At Home, Not in Bedroom | 183 Participants |
| HIV Knowledge Control | Participant Location | Other | 105 Participants |
| HIV Knowledge Control | Participant Location | At Home, Not in Bedroom | 213 Participants |
| HIV Knowledge Control | Participant Location | At Home, In Bedroom | 303 Participants |
| HIV Knowledge Control | Participant Location | Coffee Shop | 29 Participants |
| HIV Knowledge Control | Participant Location | Community Center | 13 Participants |
| HIV Knowledge Control | Participant Location | Library | 36 Participants |
| HIV Knowledge Control | Participant Location | Friend's House | 36 Participants |
Other Pre-specified
Participant Rating of Intervention Acceptability and Tolerability
Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.
Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)
Population: Enrolled participants who completed assessments on intervention acceptability immediately following completion of intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Keep It Up! Intervention | Participant Rating of Intervention Acceptability and Tolerability | 3.52 units on a scale | Standard Deviation 0.41 |
| HIV Knowledge Control | Participant Rating of Intervention Acceptability and Tolerability | 3.50 units on a scale | Standard Deviation 0.41 |