HIV/AIDSNCT03551938
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
A study testing Relationship skills session for YMSM partnered-individuals and couples in people with HIV/AIDS, run by University of Michigan at 1 site in United States.
Trial summary
We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Relationship skills session for YMSM partnered-individuals and couples
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 15 to 24 years (inclusive) at time of screening
- Current U.S. resident
- Sufficient age for sexual consent in the current state of residence (assessed at both the individual and dyadic level)
- Self-identify that they are in an emotional and sexual relationship with another male
- Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man
- Self-reports that they engaged in any kind of sexual activity (oral, vaginal, anal) in their lifetime
Show all 9Show fewer
- Has access to computer/personal device/smart phone with internet access
- Self-report being HIV negative or unknown serostatus
- Speak and read English
Who cannot join
- Younger than age for consent without parental permission in the current state of residence
- Assigned female sex at birth and currently identifies as something other than male or transgender man
- Assigned male sex at birth but identifies as gender other than male or transgender man
- Aged 14 years or younger or 25 or older at the time of screening
- HIV-positive
- Not currently in an emotional and/or sexual relationship with another male
- Does not speak or read English
- Reports intimate partner violence in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Sexuality and Health Disparities
Ann Arbor, Michigan, 48109
About this study
Official title: ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). This project involves three phases to develop and pilot test the intervention. Phase I collected brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YMSM and feedback from a technical expert group (TEG) to develop and refine the two-session intervention. Phase II involved conducting a one-arm pilot of the intervention condition to further refine the intervention content with a sample of 12 YMSM (6 dyads). Phase III involves conducting a randomized controlled trial (RCT) comparing the relationship-focused intervention to a control condition, which is HIV Testing, Counseling, and Referrals (CTR) alone with a sample of 320 YMSM.
Read the detailed description
Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the US, despite stable or declining rates of infection among other groups. HIV prevention and research efforts in the US have continued to target MSM as individuals, largely focusing on messages that encourage the uptake of prevention efforts and reducing sexual risk. Recently, there has been growing interest in structural interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in contexts of risk. However, despite socio-ecological theory postulating the importance of individual, dyadic and social influences on HIV risk, there has been a dearth of intervention efforts focused at the dyadic level.
We Prevent seeks to intervene on relationship communication skills as a pathway to HIV prevention during the critical period of adolescence. The proposed activities will develop and test a relationship skills focused HIV prevention intervention for young YMSM aged 15-24 as an addition to the current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and one follow up.
Phase I of the project included collection of data from two groups of participants: 1) 30 YMSM in in-depth interviews and 8 YMSM in cognitive interviews and 2) 7 Technical Experts (TEG), for a total sample of 45 research participants.
Phase II consisted of a one-arm pilot test of the intervention condition with 6 YMSM dyads (total 12 participants). Participants completed a Baseline and 1-month follow-up assessment.
Phase III involves a pilot two-arm prospective RCT in which 320 YMSM will complete a Baseline assessment and then complete assessments every 3 months for 9 months.
Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platforms, VSee and Zoom.
Specific Aims:
Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners.
Phase III: To conduct a randomized controlled trial (RCT) comparing the efficacy of the adapted intervention for 15-24 year old YMSM versus a control condition, which is CTR or CHTC alone.
- Conditions
- HIV/AIDS
- Being tested
- Relationship skills session for YMSM partnered-individuals and couples
- Keywords
- HIV, telehealth, HIV testing, YMSM, couples
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship skills session for YMSM partnered-individuals and couplesBehavioural
Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. |
| Intervention | Experimental | Receive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session. Receives: Behavioral: Relationship skills session for YMSM partnered-individuals and couples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Measured: The number of participants who report sexual risk behavior at 3 months.
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Measured: The number of participants who report sexual risk behavior at 6 months.
Sexual Risk Behavior
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Measured: The number of participants who report sexual risk behavior at 9 months.
Secondary outcomes (12)
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale .Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Measured: Mean at 3 months
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Measured: Mean at 6 months
HIV Communication
Participants completed the 9-item Couples Efficacy to Reduce HIV Threat scale. Participants responded to each item on 5-point Likert scale ranging from (1) strongly disagree to (5) strongly agree. The items were mean centered such that higher scores indicate that participants perceive that they can effectively communicate with their partner about HIV prevention strategies (range 1 to 5).
Measured: Mean at 9 months
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no).
Measured: The number of participants at 3 months
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Measured: The number of participants at 6 months
PrEP Use
Current PrEP use, which a self-report measure of whether the participant is currently using PrEP (yes/no)
Measured: The number of participants at 9 months
HIV Testing
Self-reported HIV testing in the past 3 months
Measured: The number of participants at 3-months
HIV Testing
Self-reported HIV testing in the past 3 months
Measured: The number of participants at 6 months
HIV Testing
Self-reported HIV testing in the past 3 months
Measured: The number of participants at 9 months
STI Testing
Any self-reported STI testing in the past 3 months
Measured: The number of participants at 3 months
STI Testing
Any self-reported STI testing in the past 3 months
Measured: The number of participants at 6 months
STI Testing
Any self-reported STI testing in the past 3 months
Measured: The number of participants at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start28 Jun 2018
- Primary completion13 Jul 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Rob Stephenson, PhD, Principal investigator, University of MichiganKristi Gamarel, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551938
- Sponsor's protocol ID
- FWA00004801
- Other IDs
- 5U19HD089881-04
- Status last verified
- May 2023
- First submitted
- 15 May 2018
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 2;8(1):e10370. doi: 10.2196/10370.
PubMed 30602433
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
- ClinicalTrials.gov ID
- NCT03551938
- Acronym / sponsor ID
- FWA00004801
- Conditions
- HIV/AIDS
- Keywords
- HIV, telehealth, HIV testing, YMSM, couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We Prevent seeks to develop and pilot test a developmentally-appropriate relationship skills session as an addition to the current Couples HIV Testing and Counseling (CHTC) intervention for young gay, bisexual and other men who have sex with men (YMSM). This project involves three phases to develop and pilot test the intervention. Phase I collected brief quantitative survey data, in-depth qualitative interview data, and cognitive interview data from YMSM and feedback from a technical expert group (TEG) to develop and refine the two-session intervention. Phase II involved conducting a one-arm pilot of the intervention condition to further refine the intervention content with a sample of 12 YMSM (6 dyads). Phase III involves conducting a randomized controlled trial (RCT) comparing the relationship-focused intervention to a control condition, which is HIV Testing, Counseling, and Referrals (CTR) alone with a sample of 320 YMSM.
Detailed description
Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the US, despite stable or declining rates of infection among other groups. HIV prevention and research efforts in the US have continued to target MSM as individuals, largely focusing on messages that encourage the uptake of prevention efforts and reducing sexual risk. Recently, there has been growing interest in structural interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in contexts of risk. However, despite socio-ecological theory postulating the importance of individual, dyadic and social influences on HIV risk, there has been a dearth of intervention efforts focused at the dyadic level.
We Prevent seeks to intervene on relationship communication skills as a pathway to HIV prevention during the critical period of adolescence. The proposed activities will develop and test a relationship skills focused HIV prevention intervention for young YMSM aged 15-24 as an addition to the current HIV Counseling, Testing, and Referrals (CTR) and Couples HIV Testing and Counseling (CHTC). At home STI test kits will also be sent in Phases II and III at baseline and one follow up.
Phase I of the project included collection of data from two groups of participants: 1) 30 YMSM in in-depth interviews and 8 YMSM in cognitive interviews and 2) 7 Technical Experts (TEG), for a total sample of 45 research participants.
Phase II consisted of a one-arm pilot test of the intervention condition with 6 YMSM dyads (total 12 participants). Participants completed a Baseline and 1-month follow-up assessment.
Phase III involves a pilot two-arm prospective RCT in which 320 YMSM will complete a Baseline assessment and then complete assessments every 3 months for 9 months.
Recruitment of all participants is in all 50 states and will be conducted through popular social media sites (e.g. Facebook). All interviews will be conducted through the HIPAA video-conferencing platforms, VSee and Zoom.
Specific Aims:
Phases I and II: To develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention for 15-19 year old YMSM and their partners.
Phase III: To conduct a randomized controlled trial (RCT) comparing the efficacy of the adapted intervention for 15-24 year old YMSM versus a control condition, which is CTR or CHTC alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive only the standard HIV Counseling, Testing, and Referral or Couples HIV Testing and Counseling (CHTC) Session. |
| Intervention | Experimental | Behavioral: Relationship skills session for YMSM partnered-individuals and couplesReceive one 45-minute Relationship skills session for YMSM individuals and couples (the intervention) as an addition to the standard HIV Counseling, Testing, and Referral (CTR) or Couples HIV Testing and Counseling (CHTC) Session. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Ages 15 to 24 years (inclusive) at time of screening
- Current U.S. resident
- Sufficient age for sexual consent in the current state of residence (assessed at both the individual and dyadic level)
- Self-identify that they are in an emotional and sexual relationship with another male
- Cisgender men (assigned male sex at birth and currently identifies as male) OR transgender men (assigned female at birth and identifies as male or transgender man
Key exclusion criteria (8 listed)
- Younger than age for consent without parental permission in the current state of residence
- Assigned female sex at birth and currently identifies as something other than male or transgender man
- Assigned male sex at birth but identifies as gender other than male or transgender man
- Aged 14 years or younger or 25 or older at the time of screening
- HIV-positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship skills session for YMSM partnered-individuals and couplesRelationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners. | Behavioural | Intervention |
Primary outcome
Sexual Risk Behavior
Time frame: The number of participants who report sexual risk behavior at 3 months.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Sexual Risk Behavior
Time frame: The number of participants who report sexual risk behavior at 6 months.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
Sexual Risk Behavior
Time frame: The number of participants who report sexual risk behavior at 9 months.
Anal or vaginal intercourse without condoms or PrEP that occurs with a person of known positive or unknown serostatus during follow-up period.
12 secondary outcomes
HIV Communication
Time frame: Mean at 3 months
HIV Communication
Time frame: Mean at 6 months
HIV Communication
Time frame: Mean at 9 months
PrEP Use
Time frame: The number of participants at 3 months
PrEP Use
Time frame: The number of participants at 6 months
PrEP Use
Time frame: The number of participants at 9 months
HIV Testing
Time frame: The number of participants at 3-months
HIV Testing
Time frame: The number of participants at 6 months
HIV Testing
Time frame: The number of participants at 9 months
STI Testing
Time frame: The number of participants at 3 months
STI Testing
Time frame: The number of participants at 6 months
STI Testing
Time frame: The number of participants at 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30602433Gamarel KE, Darbes LA, Hightow-Weidman L, Sullivan P, Stephenson R. The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 2;8(1):e10370. doi: 10.2196/10370.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Stephenson, PhD principal investigator
University of Michigan
Kristi Gamarel, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship skills session for YMSM partnered-individuals and couples in people with HIV/AIDS, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Risk Behavior (time frame: The number of participants who report sexual risk behavior at 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.