HivPhase 22GETHERNCT03284541
Online HIV Prevention for Young Male Couples
A Phase 2 study testing 2GETHER and Existing Public Health Practice in people with Hiv and Chlamydia, run by Northwestern University at 1 site in United States.
Trial summary
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- 2GETHER and Existing Public Health Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 1 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both members of the couple assigned male at birth and currently identify as male
- Both members of the couples at least 18 years of age; at least one between the ages of 18-29 years
- Both members of the couple identify one another as primary partners
- Couple has had oral or anal sex with one another in the past 3 months
- At least one member of the couple reports condomless anal sex with a serodiscordant or unknown status partner during the past 3 months
- At least one member of the couple reports an episode of binge-drinking or illicit drug use during the last 30 days
Show all 9Show fewer
- Both members of the couple read and speak English at 8th grade level or better
- Both members have Internet access
- Both members audio recording of intervention sessions
Who cannot join
- Severe intimate partner violence during the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population.
Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, they were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple.
Read more
The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment.
The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be implemented online; both the experimental and control condition will be administered via video-conferencing technology to couples across the United States. The investigators will conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on the HIV status of individuals in the dyad. Couples in which both members are HIV-negative will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol. Couples in which both members are HIV-positive will receive the single session Life-Steps medication adherence protocol. Couples with discordant HIV statuses will receive both interventions jointly.
- Being tested
- 2GETHER, Existing Public Health Practice
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2GETHERBehavioural
Communication skills, coping skills, problem-solving, acceptance, HIV prevention
Existing Public Health PracticeBehavioural
HIV testing, medication adherence, HIV risk reduction
| Study group | Role | What they receive |
|---|---|---|
| 2GETHER | Experimental | 2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple. Receives: Behavioral: 2GETHER |
| Existing Public Health Practice | Active comparator | The control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples Receives: Behavioral: Existing Public Health Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless anal sex
change in number of condomless anal sex acts with serodiscordant or unknown status partners
Measured: 12-months
Occurrence of Sexually Transmitted Infections
the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months
Measured: 12-months
Secondary outcomes (5)
HIV Testing
frequency of HIV testing among HIV-negative or unknown status participants
Measured: Baseline, 3-, 6-, 9-, 12-months
HIV Viral Load
change in serum viral load among HIV-positive participants
Measured: Baseline, 12-months
Alcohol and Drug Use Problems
change in problems associated with alcohol, marijuana and other illicit drug use
Measured: Baseline, 3-, 6-, 9-, 12-months
Relationship Satisfaction
change in relationship satisfaction
Measured: Baseline, 3-, 6-, 9-, 12-months
Communication Skills
change in communication skills with romantic partners
Measured: Baseline, 3-, 6-, 9-, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start5 Apr 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples are randomized into an experimental condition or control (existing public health practice).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael E. Newcomb, Northwestern University
- Investigators
- Michael E Newcomb, Ph.D., Principal investigator, Northwestern UniversityJim Carey, MPH, Study director, Northwestern UniversityRicky Hill, Ph.D., Study director, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284541
- Sponsor's protocol ID
- DP2DA042417
- Acronym
- 2GETHER
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2017
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.
PubMed 19417579Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.
PubMed 25678895Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.
PubMed 24980246Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.
PubMed 22283386Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.
PubMed 28083833Smith MS, Newcomb ME. Substance Use and Relationship Functioning Among Young Male Couples. Arch Sex Behav. 2023 Jul;52(5):2097-2110. doi: 10.1007/s10508-023-02627-1. Epub 2023 Jun 23.
PubMed 37351709Newcomb ME, Swann G, Macapagal K, Sarno EL, Whitton SW, Mustanski B. Biomedical and behavioral outcomes of 2GETHER: A randomized controlled trial of a telehealth HIV prevention program for young male couples. J Consult Clin Psychol. 2023 Sep;91(9):505-520. doi: 10.1037/ccp0000823. Epub 2023 May 4.
PubMed 37141032Newcomb ME, Sarno EL, Bettin E, Carey J, Ciolino JD, Hill R, Garcia CP, Macapagal K, Mustanski B, Swann G, Whitton SW. Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER. JMIR Res Protoc. 2020 Jan 27;9(1):e15883. doi: 10.2196/15883.
PubMed 32012111
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
- ClinicalTrials.gov ID
- NCT03284541
- Acronym / sponsor ID
- 2GETHER / DP2DA042417
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population.
Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, they were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple.
The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment.
The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be implemented online; both the experimental and control condition will be administered via video-conferencing technology to couples across the United States. The investigators will conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on the HIV status of individuals in the dyad. Couples in which both members are HIV-negative will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol. Couples in which both members are HIV-positive will receive the single session Life-Steps medication adherence protocol. Couples with discordant HIV statuses will receive both interventions jointly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Couples are randomized into an experimental condition or control (existing public health practice).
| Arm | Type | Receives |
|---|---|---|
| 2GETHER | Experimental | Behavioral: 2GETHER2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple. |
| Existing Public Health Practice | Active comparator | Behavioral: Existing Public Health PracticeThe control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Both members of the couple assigned male at birth and currently identify as male
- Both members of the couples at least 18 years of age; at least one between the ages of 18-29 years
- Both members of the couple identify one another as primary partners
- Couple has had oral or anal sex with one another in the past 3 months
- At least one member of the couple reports condomless anal sex with a serodiscordant or unknown status partner during the past 3 months
Key exclusion criteria (1 listed)
- Severe intimate partner violence during the past 3 months
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 |
|---|---|---|
| 2GETHERCommunication skills, coping skills, problem-solving, acceptance, HIV prevention | Behavioural | 2GETHER |
| Existing Public Health PracticeHIV testing, medication adherence, HIV risk reduction | Behavioural | Existing Public Health Practice |
Primary outcome
Condomless anal sex
Time frame: 12-months
change in number of condomless anal sex acts with serodiscordant or unknown status partners
Occurrence of Sexually Transmitted Infections
Time frame: 12-months
the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months
5 secondary outcomes
HIV Testing
Time frame: Baseline, 3-, 6-, 9-, 12-months
HIV Viral Load
Time frame: Baseline, 12-months
Alcohol and Drug Use Problems
Time frame: Baseline, 3-, 6-, 9-, 12-months
Relationship Satisfaction
Time frame: Baseline, 3-, 6-, 9-, 12-months
Communication Skills
Time frame: Baseline, 3-, 6-, 9-, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 19417579Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.
- Background: PubMed 25678895Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.
- Background: PubMed 24980246Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.
- Background: PubMed 22283386Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.
- Background: PubMed 28083833Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.
- Derived from this study: PubMed 37351709Smith MS, Newcomb ME. Substance Use and Relationship Functioning Among Young Male Couples. Arch Sex Behav. 2023 Jul;52(5):2097-2110. doi: 10.1007/s10508-023-02627-1. Epub 2023 Jun 23.
- Derived from this study: PubMed 37141032Newcomb ME, Swann G, Macapagal K, Sarno EL, Whitton SW, Mustanski B. Biomedical and behavioral outcomes of 2GETHER: A randomized controlled trial of a telehealth HIV prevention program for young male couples. J Consult Clin Psychol. 2023 Sep;91(9):505-520. doi: 10.1037/ccp0000823. Epub 2023 May 4.
- Derived from this study: PubMed 32012111Newcomb ME, Sarno EL, Bettin E, Carey J, Ciolino JD, Hill R, Garcia CP, Macapagal K, Mustanski B, Swann G, Whitton SW. Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER. JMIR Res Protoc. 2020 Jan 27;9(1):e15883. doi: 10.2196/15883.
- Individual participant dataSharing planned: Undecided
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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.
Michael E Newcomb, Ph.D. principal investigator
Northwestern University
Jim Carey, MPH study director
Northwestern University
Ricky Hill, Ph.D. study director
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2GETHER and Existing Public Health Practice in people with Hiv and Chlamydia, run by Northwestern University 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 1 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 28 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Condomless anal sex (time frame: 12-months). The study lists 2 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 NCT03284541, which also lists 8 linked publications.
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 28 Jul 2023.