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Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents

HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00640653
Enrollment
662
Registered
2008-03-21
Start date
2001-09-30
Completion date
2004-08-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Diseases

Keywords

Sexual Behavior, Abstinence, Intervention Studies, HIV, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity

Brief summary

This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually transmitted disease risk-reduction interventions in reducing sexual risk behavior among young African-American adolescents.

Detailed description

Adolescents risk the negative consequences of early sexual involvement, including not only HIV, but other sexually transmitted diseases (STDs) and unintended pregnancies. Compared with older adults, young people, especially African-American young people, are at higher risk of acquiring an STD. Specifically, people 15 to 24 years of age acquire nearly 50% of all new STDs in the United States, but this age group represents only 25% of the sexually active population. Adolescents are especially vulnerable to STD infections because of a lack of education about proper condom use and consequences of sexual risk behaviors. Previous research has suggested that behavioral interventions can reduce adolescents' sexual behaviors tied to risk of acquiring STDs. Nevertheless, there is continuous debate over the appropriateness and effectiveness of different types of adolescent sexual-risk-reduction interventions, including abstinence education or comprehensive sexual education. Few studies have tested the long-term effectiveness of abstinence education, which emphasizes delaying sexual initiation for sexually inexperienced adolescents. This study will compare the effectiveness of an abstinence-only HIV/STD risk-reduction intervention with other types of interventions in reducing sexual risk behavior among young African-American adolescents. Participation in this study will last 24 months. Participants at participating schools will be randomly assigned to one of five treatment groups: * Abstinence-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. This is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention is not designed to affect condom use. * Safer-sex-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence. * Long comprehensive group participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention will consist of 4 hours each of the safer-sex-specific content, the abstinence-specific content, and the general content that is common to both of the single-component interventions. * Short comprehensive group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. * Health promotion control participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. Sessions for all groups will be led by trained adult facilitators and will include group discussions, videos, games, brainstorming, experiential exercises, and skill-building activities designed to be educational, interactive, and entertaining. All participants will complete self-reports concerning sexual behaviors, condom use, and knowledge about STDs at baseline and Months 3, 6, 12, 18, and 24 of follow-up.

Interventions

BEHAVIORALAbstinence-only HIV/STD risk-reduction intervention

Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use.

BEHAVIORALSafer-sex-only HIV/STD risk-reduction intervention

Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.

BEHAVIORALLong comprehensive HIV/STD risk-reduction intervention

Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours).

BEHAVIORALShort comprehensive HIV/STD risk-reduction intervention

Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.

BEHAVIORALHealth promotion control intervention

Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Grade 6 or 7 student at a participating school * Written parent or guardian consent to participate * Self-identifies as African American or black

Exclusion criteria

\- Those not meeting inclusion criteria were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Self-report of Ever Having Sexual Intercourse24 months post-interventionSelf-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

Secondary

MeasureTime frameDescription
Self-reported Sexual Intercourse in the Past 3 MonthsMeasured at baseline and 3, 6, 12, 18, and 24 months post-interventionSelf-report of having sexual intercourse in the past 3 months
Self-report of Having Multiple Sexual Partners in the Past 3 MonthsMeasured at baseline and 3, 6, 12, 18, and 24 months post-interventionSelf-report of having sexual intercourse with more than one partner in the pat 3 months.
Self-reported Consistent Condom Use in the Past 3 MonthsMeasured at baseline and 3, 6, 12, 18, and 24 months post-interventionSelf-report of using a condom during every sexual intercourse act in the past 3 months
Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsMeasured at baseline and3, 6, 12, 18, and 24 months post-intervention

Countries

United States

Participant flow

Participants by arm

ArmCount
Comprehensive-long
Participants will receive the long comprehensive HIV/STD risk-reduction intervention. Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours).
131
Comprehensive-short
Participants will receive the short comprehensive HIV/STD risk-reduction intervention. Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.
134
Safer-sex Only
Participants will receive the safer-sex-only HIV/STD risk-reduction intervention. Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.
129
Abstinence-only
Participants will receive the abstinence-only HIV/STD risk-reduction intervention. Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use.
134
Health-promotion Control
Participants will receive the health promotion control intervention. Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention.
134
Total662

Baseline characteristics

CharacteristicAbstinence-onlyComprehensive-longSafer-sex OnlyComprehensive-shortTotalHealth-promotion Control
Age, Continuous12.0 years
STANDARD_DEVIATION 0.8
12.0 years
STANDARD_DEVIATION 0.8
11.9 years
STANDARD_DEVIATION 0.8
11.9 years
STANDARD_DEVIATION 0.8
12.0 years
STANDARD_DEVIATION 0.8
12.0 years
STANDARD_DEVIATION 0.8
Ever had sexual intercourse
No
107 participants100 participants97 participants106 participants509 participants99 participants
Ever had sexual intercourse
Yes
27 participants31 participants32 participants28 participants153 participants35 participants
Grade in School
7th
77 participants68 participants73 participants71 participants366 participants77 participants
Grade in School
8th
57 participants63 participants56 participants63 participants296 participants57 participants
Live with both parents
No
91 participants85 participants89 participants88 participants441 participants88 participants
Live with both parents
Yes
43 participants46 participants40 participants46 participants221 participants46 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
134 Participants131 Participants129 Participants134 Participants662 Participants134 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
134 participants131 participants129 participants134 participants662 participants134 participants
Sex: Female, Male
Female
70 Participants69 Participants70 Participants72 Participants354 Participants73 Participants
Sex: Female, Male
Male
64 Participants62 Participants59 Participants62 Participants308 Participants61 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 1310 / 1340 / 1290 / 1340 / 134
serious
Total, serious adverse events
0 / 1310 / 1340 / 1290 / 1340 / 134

Outcome results

Primary

Self-report of Ever Having Sexual Intercourse

Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

Time frame: 24 months post-intervention

Population: Participants reporting never having sexual intercourse at baseline (i.e., virgins) with follow-up data on self-reported sexual intercourse during the post-intervention assessments.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Comprehensive-longSelf-report of Ever Having Sexual Intercourse39 Participants
Comprehensive-shortSelf-report of Ever Having Sexual Intercourse40 Participants
Safer-sex OnlySelf-report of Ever Having Sexual Intercourse44 Participants
Abstinence-onlySelf-report of Ever Having Sexual Intercourse31 Participants
Health-promotion ControlSelf-report of Ever Having Sexual Intercourse41 Participants
Comparison: With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.p-value: 0.0395% CI: [0.48, 0.96]generalized linear regression
Secondary

Self-reported Consistent Condom Use in the Past 3 Months

Self-report of using a condom during every sexual intercourse act in the past 3 months

Time frame: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post intervention assessment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 MonthsBaseline7 Participants
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 Months3-Months8 Participants
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 Months6-Months14 Participants
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 Months12-Months16 Participants
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 Months18-Months23 Participants
Comprehensive-longSelf-reported Consistent Condom Use in the Past 3 Months24-Months26 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 Months18-Months21 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 Months24-Months29 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 MonthsBaseline8 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 Months6-Months17 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 Months12-Months25 Participants
Comprehensive-shortSelf-reported Consistent Condom Use in the Past 3 Months3-Months15 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 Months12-Months24 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 Months18-Months34 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 MonthsBaseline4 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 Months6-Months17 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 Months3-Months16 Participants
Safer-sex OnlySelf-reported Consistent Condom Use in the Past 3 Months24-Months31 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 Months12-Months19 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 Months3-Months12 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 Months6-Months11 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 Months24-Months25 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 Months18-Months31 Participants
Abstinence-onlySelf-reported Consistent Condom Use in the Past 3 MonthsBaseline10 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 Months18-Months27 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 Months6-Months15 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 Months3-Months20 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 Months24-Months32 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 Months12-Months17 Participants
Health-promotion ControlSelf-reported Consistent Condom Use in the Past 3 MonthsBaseline12 Participants
Secondary

Self-reported Sexual Intercourse in the Past 3 Months

Self-report of having sexual intercourse in the past 3 months

Time frame: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post-intervention assessment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 MonthsBaseline14 Participants
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 Months3 months12 Participants
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 Months6 months18 Participants
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 Months12 months24 Participants
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 Months18 months32 Participants
Comprehensive-longSelf-reported Sexual Intercourse in the Past 3 Months24 months35 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 Months18 months32 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 Months24 months38 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 MonthsBaseline13 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 Months6 months19 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 Months12 months33 Participants
Comprehensive-shortSelf-reported Sexual Intercourse in the Past 3 Months3 months19 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 Months12 months34 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 Months18 months40 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 MonthsBaseline15 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 Months6 months21 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 Months3 months22 Participants
Safer-sex OnlySelf-reported Sexual Intercourse in the Past 3 Months24 months42 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 Months12 months27 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 Months3 months15 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 Months6 months13 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 Months24 months33 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 Months18 months39 Participants
Abstinence-onlySelf-reported Sexual Intercourse in the Past 3 MonthsBaseline16 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 Months18 months35 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 Months6 months27 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 Months3 months26 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 Months24 months42 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 Months12 months25 Participants
Health-promotion ControlSelf-reported Sexual Intercourse in the Past 3 MonthsBaseline18 Participants
Secondary

Self-report of Having Multiple Sexual Partners in the Past 3 Months

Self-report of having sexual intercourse with more than one partner in the pat 3 months.

Time frame: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post-intervention assessment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 MonthsBaseline11 Participants
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 Months3 months7 Participants
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 Months6 months7 Participants
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 Months12 months13 Participants
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 Months18 months9 Participants
Comprehensive-longSelf-report of Having Multiple Sexual Partners in the Past 3 Months24 months16 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 Months18 months16 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 Months24 months13 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 MonthsBaseline9 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 Months6 months6 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 Months12 months9 Participants
Comprehensive-shortSelf-report of Having Multiple Sexual Partners in the Past 3 Months3 months6 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 Months12 months14 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 Months18 months17 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 MonthsBaseline6 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 Months6 months7 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 Months3 months12 Participants
Safer-sex OnlySelf-report of Having Multiple Sexual Partners in the Past 3 Months24 months17 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 Months12 months11 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 Months3 months5 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 Months6 months4 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 Months24 months14 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 Months18 months21 Participants
Abstinence-onlySelf-report of Having Multiple Sexual Partners in the Past 3 MonthsBaseline4 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 Months18 months17 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 Months6 months18 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 Months3 months14 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 Months24 months17 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 Months12 months10 Participants
Health-promotion ControlSelf-report of Having Multiple Sexual Partners in the Past 3 MonthsBaseline10 Participants
Secondary

Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months

Time frame: Measured at baseline and3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post intervention assessment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months6-Months2 Participants
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsBaseline3 Participants
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months12-Months7 Participants
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months3-Months5 Participants
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months24-Months8 Participants
Comprehensive-longSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months18-Months6 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months6-Months1 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months24-Months8 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months12-Months6 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months3-Months2 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsBaseline2 Participants
Comprehensive-shortSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months18-Months10 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months18-Months3 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months24-Months8 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months3-Months4 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months6-Months3 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsBaseline7 Participants
Safer-sex OnlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months12-Months6 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months18-Months8 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months12-Months7 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsBaseline1 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months3-Months1 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months24-Months8 Participants
Abstinence-onlySelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months6-Months1 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months24-Months8 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 MonthsBaseline5 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months3-Months4 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months6-Months11 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months12-Months7 Participants
Health-promotion ControlSelf-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months18-Months7 Participants

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026