HIV
Conditions
Keywords
HIV prevention, Toolkit, Male couples, Sexual agreements
Brief summary
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design. Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules. The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples. For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project. After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples. The interactive website, herein referred to as the HIV prevention toolkit will contain unique modules about sexual agreements and effective HIV prevention strategies.
Interventions
BEHAVIORALMale Couples Agreement Project
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Sponsors
National Institute of Mental Health (NIMH)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligible male couples: 1. are identified as two men (i.e., main partners) who had been in a sexual relationship together for \> 6 months; 2. are at least 18 years of age; 3. are self-reported as being HIV-negative; 4. had been practicing CAS in their relationship for \> 6 months; 5. report no recent history (\< 1 year) of intimate partner violence (IPV) or coercion; 6. have had no current sexual agreement; and 7. own a smartphone and have an alternate method to access the Internet (e.g., computer).
Exclusion criteria
1. Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study. 2. Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study. 3. Adults who are unable to consent; 4. Individuals who are not yet adults; 5. Pregnant and non-pregnant women, and prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Formation of a Sexual Agreement at 6 Months | 6 month | Self-reports of yes/no to forming a sexual agreement via electronic survey |
| Adherence to a Sexual Agreement at 6 Months | 6 month | Self-report of yes/no of adhering to a sexual agreement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | 3 month | Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey |
| Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | month 6 | Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6). |
| Formation of a Sexual Agreement at 3 Months | 3 month | Self-reports of yes/no to forming a sexual agreement via electronic survey |
| Test for HIV During the Last 3 Months (Months 3-6) | month 6 | Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6. |
| Test for HIV During Past 3 Months (Months 0-3) | 3 month | Self-reports of yes/no via electronic survey taken at 3 month. |
| Adherence to a Sexual Agreement | 3 month | Self-reports of yes/no to adhering to a sexual agreement via electronic survey |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center. | 162 |
| Intervention Group Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center. | 136 |
| Total | 298 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 27.55 years STANDARD_DEVIATION 7.03 | 28.13 years STANDARD_DEVIATION 7.33 | 27.81 years STANDARD_DEVIATION 7.03 |
| Education Bachelors degree | 45 Participants | 29 Participants | 74 Participants |
| Education Graduate degree | 14 Participants | 19 Participants | 33 Participants |
| Education High School graduate / GED | 20 Participants | 22 Participants | 42 Participants |
| Education missing data | 2 Participants | 0 Participants | 2 Participants |
| Education Some college / AA / trade | 61 Participants | 56 Participants | 117 Participants |
| Education Some grad school | 13 Participants | 7 Participants | 20 Participants |
| Education Some High School | 7 Participants | 3 Participants | 10 Participants |
| Employment Full time | 106 Participants | 90 Participants | 196 Participants |
| Employment On disability | 8 Participants | 4 Participants | 12 Participants |
| Employment Part time | 18 Participants | 16 Participants | 34 Participants |
| Employment Retired | 1 Participants | 0 Participants | 1 Participants |
| Employment Student | 21 Participants | 19 Participants | 40 Participants |
| Employment Unemployed | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 112 Participants | 250 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Had sex with casual male partner (outside relationship) No, not within last 3 months | 133 Participants | 98 Participants | 231 Participants |
| Had sex with casual male partner (outside relationship) Yes within last 3 months | 29 Participants | 38 Participants | 67 Participants |
| HIV testing frequency (before relationship) Every 3-4 months | 24 Participants | 15 Participants | 39 Participants |
| HIV testing frequency (before relationship) Every 6 months | 33 Participants | 28 Participants | 61 Participants |
| HIV testing frequency (before relationship) Missing data | 28 Participants | 20 Participants | 48 Participants |
| HIV testing frequency (before relationship) No testing pattern | 23 Participants | 21 Participants | 44 Participants |
| HIV testing frequency (before relationship) Once a year | 29 Participants | 30 Participants | 59 Participants |
| HIV testing frequency (before relationship) When I dated someone new | 6 Participants | 4 Participants | 10 Participants |
| HIV testing frequency (before relationship) When I felt at risk for HIV | 19 Participants | 18 Participants | 37 Participants |
| HIV testing frequency (since in relationship) Every 3-4 months | 8 Participants | 0 Participants | 8 Participants |
| HIV testing frequency (since in relationship) Every 6 months | 14 Participants | 11 Participants | 25 Participants |
| HIV testing frequency (since in relationship) Missing data | 60 Participants | 41 Participants | 101 Participants |
| HIV testing frequency (since in relationship) No testing pattern | 38 Participants | 41 Participants | 79 Participants |
| HIV testing frequency (since in relationship) Once a year | 26 Participants | 23 Participants | 49 Participants |
| HIV testing frequency (since in relationship) When I felt at risk for HIV | 16 Participants | 20 Participants | 36 Participants |
| Length of current relationship 10 + years | 4 Participants | 8 Participants | 12 Participants |
| Length of current relationship 1-3 years | 69 Participants | 42 Participants | 111 Participants |
| Length of current relationship 3-6 months | 7 Participants | 8 Participants | 15 Participants |
| Length of current relationship 3-6 years | 34 Participants | 37 Participants | 71 Participants |
| Length of current relationship 6-10 years | 8 Participants | 16 Participants | 24 Participants |
| Length of current relationship 6-12 months | 40 Participants | 25 Participants | 65 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 147 Participants | 119 Participants | 266 Participants |
| Region of Enrollment United States | 162 participants | 136 participants | 298 participants |
| Region of residence Midwest | 35 Participants | 48 Participants | 83 Participants |
| Region of residence Northeast | 19 Participants | 11 Participants | 30 Participants |
| Region of residence South | 67 Participants | 39 Participants | 106 Participants |
| Region of residence US territory | 2 Participants | 2 Participants | 4 Participants |
| Region of residence West | 39 Participants | 36 Participants | 75 Participants |
| Relationship status Domestic partnership | 42 Participants | 28 Participants | 70 Participants |
| Relationship status Engaged | 27 Participants | 28 Participants | 55 Participants |
| Relationship status Married | 24 Participants | 40 Participants | 64 Participants |
| Relationship status None of the above | 62 Participants | 31 Participants | 93 Participants |
| Relationship status Other | 7 Participants | 9 Participants | 16 Participants |
| Relationship type missing data | 1 Participants | 0 Participants | 1 Participants |
| Relationship type Monogamous | 153 Participants | 117 Participants | 270 Participants |
| Relationship type No label and other | 3 Participants | 5 Participants | 8 Participants |
| Relationship type Open | 5 Participants | 14 Participants | 19 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 162 Participants | 136 Participants | 298 Participants |
| Sexual orientation bisexual | 6 Participants | 3 Participants | 9 Participants |
| Sexual orientation gay | 156 Participants | 133 Participants | 289 Participants |
| When started having anal sex in relationship | 5.24 weeks STANDARD_DEVIATION 10.25 | 5.96 weeks STANDARD_DEVIATION 9.59 | 5.57 weeks STANDARD_DEVIATION 9.95 |
| When started having condomless anal sex in relationship | 10.98 weeks STANDARD_DEVIATION 20.09 | 22.91 weeks STANDARD_DEVIATION 44.38 | 16.42 weeks STANDARD_DEVIATION 31.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 136 |
| other Total, other adverse events | 0 / 162 | 0 / 136 |
| serious Total, serious adverse events | 0 / 162 | 0 / 136 |
Outcome results
Primary
Adherence to a Sexual Agreement at 6 Months
Self-report of yes/no of adhering to a sexual agreement
Time frame: 6 month
Population: Participants who provided data in outcome 1 as having a concordant agreement were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Adherence to a Sexual Agreement at 6 Months | Adhered to the agreement | 48 Participants |
| Control Group | Adherence to a Sexual Agreement at 6 Months | Did not adhere to the agreement | 8 Participants |
| Intervention Group | Adherence to a Sexual Agreement at 6 Months | Adhered to the agreement | 60 Participants |
| Intervention Group | Adherence to a Sexual Agreement at 6 Months | Did not adhere to the agreement | 6 Participants |
Primary
Formation of a Sexual Agreement at 6 Months
Self-reports of yes/no to forming a sexual agreement via electronic survey
Time frame: 6 month
Population: For control, 115 men (52 dyads both partners provided data and 11 dyads where only one partner provided data) provided outcome data.~For intervention, 98 men (45 dyads where both partners provided data and 8 dyads where only one partner provided data) provided outcome data.~Only dyads where both partners provided data were included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Formation of a Sexual Agreement at 6 Months | Formed an agreement | 56 Participants |
| Control Group | Formation of a Sexual Agreement at 6 Months | Did not form an agreement | 48 Participants |
| Intervention Group | Formation of a Sexual Agreement at 6 Months | Formed an agreement | 66 Participants |
| Intervention Group | Formation of a Sexual Agreement at 6 Months | Did not form an agreement | 24 Participants |
Secondary
Adherence to a Sexual Agreement
Self-reports of yes/no to adhering to a sexual agreement via electronic survey
Time frame: 3 month
Population: Participants who provided data in outcome 3 as having a concordant agreement were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Adherence to a Sexual Agreement | Adhered to the agreement | 62 Participants |
| Control Group | Adherence to a Sexual Agreement | Did not adhere to the agreement | 8 Participants |
| Intervention Group | Adherence to a Sexual Agreement | Adhered to the agreement | 54 Participants |
| Intervention Group | Adherence to a Sexual Agreement | Did not adhere to the agreement | 4 Participants |
Secondary
Formation of a Sexual Agreement at 3 Months
Self-reports of yes/no to forming a sexual agreement via electronic survey
Time frame: 3 month
Population: 206 partnered men represent 44 dyads in the intervention arm and 59 dyads in the control arm, respectively. Couple-level findings are reported at the individual level.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Formation of a Sexual Agreement at 3 Months | Formed an agreement | 70 Participants |
| Control Group | Formation of a Sexual Agreement at 3 Months | Did not form an agreement | 48 Participants |
| Intervention Group | Formation of a Sexual Agreement at 3 Months | Formed an agreement | 58 Participants |
| Intervention Group | Formation of a Sexual Agreement at 3 Months | Did not form an agreement | 30 Participants |
Secondary
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
Time frame: 3 month
Population: 9 of 125 participants in control did not provide data, and 9 of 92 participants in intervention did not provide data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Had CAS | 7 Participants |
| Control Group | Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Did not have CAS | 109 Participants |
| Intervention Group | Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Had CAS | 5 Participants |
| Intervention Group | Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3 | Did not have CAS | 78 Participants |
Secondary
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
Time frame: month 6
Population: Of control participants, only 104 of 115 provided data for this outcome. Of intervention participants, only 90 of 98 provided data for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Had CAS | 5 Participants |
| Control Group | Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Did not have CAS | 99 Participants |
| Intervention Group | Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Had CAS | 4 Participants |
| Intervention Group | Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6 | Did not have CAS | 86 Participants |
Secondary
Test for HIV During Past 3 Months (Months 0-3)
Self-reports of yes/no via electronic survey taken at 3 month.
Time frame: 3 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Test for HIV During Past 3 Months (Months 0-3) | Yes, within last 3 months | 27 Participants |
| Control Group | Test for HIV During Past 3 Months (Months 0-3) | No, not within last 3 months | 98 Participants |
| Intervention Group | Test for HIV During Past 3 Months (Months 0-3) | Yes, within last 3 months | 15 Participants |
| Intervention Group | Test for HIV During Past 3 Months (Months 0-3) | No, not within last 3 months | 77 Participants |
Secondary
Test for HIV During the Last 3 Months (Months 3-6)
Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.
Time frame: month 6
Population: 213 partnered men who completed 6-month assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Test for HIV During the Last 3 Months (Months 3-6) | Yes, within last 3 months | 27 Participants |
| Control Group | Test for HIV During the Last 3 Months (Months 3-6) | No, not within last 3 months | 88 Participants |
| Intervention Group | Test for HIV During the Last 3 Months (Months 3-6) | Yes, within last 3 months | 11 Participants |
| Intervention Group | Test for HIV During the Last 3 Months (Months 3-6) | No, not within last 3 months | 87 Participants |