HIVMCAPNCT02494817
HIV Prevention Toolkit for HIV-negative Male Couples
A study testing Male Couples Agreement Project in people with HIV, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Male Couples Agreement Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible male couples:
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
- have had no current sexual agreement; and
- own a smartphone and have an alternate method to access the Internet (e.g., computer).
Who cannot join
- 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.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
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.
- Conditions
- HIV
- Being tested
- Male Couples Agreement Project
- Keywords
- HIV prevention, Toolkit, Male couples, Sexual agreements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male Couples Agreement ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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. Receives: Behavioral: Male Couples Agreement Project |
| Intervention group | Active comparator | 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. Receives: Behavioral: Male Couples Agreement Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation of a Sexual Agreement at 6 Months
Self-reports of yes/no to forming a sexual agreement via electronic survey
Measured: 6 month
Adherence to a Sexual Agreement at 6 Months
Self-report of yes/no of adhering to a sexual agreement
Measured: 6 month
Secondary outcomes (6)
Formation of a Sexual Agreement at 3 Months
Self-reports of yes/no to forming a sexual agreement via electronic survey
Measured: 3 month
Adherence to a Sexual Agreement
Self-reports of yes/no to adhering to a sexual agreement via electronic survey
Measured: 3 month
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
Measured: 3 month
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).
Measured: month 6
Test for HIV During Past 3 Months (Months 0-3)
Self-reports of yes/no via electronic survey taken at 3 month.
Measured: 3 month
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.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
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 HIVStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Daniel J Feaster, University of Miami
- Investigators
- Jason W Mitchell, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494817
- Sponsor's protocol ID
- 20140561
- Other IDs
- R34MH102098
- Acronym
- MCAP
- Status last verified
- Mar 2019
- First submitted
- 7 Jul 2015
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mitchell JW, Lee JY, Wu Y, Sullivan PS, Stephenson R. Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Feb 13;4(2):e16807. doi: 10.2196/16807.
PubMed 32044754
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
- ClinicalTrials.gov ID
- NCT02494817
- Acronym / sponsor ID
- MCAP / 20140561
- Conditions
- HIV
- Keywords
- HIV prevention, Toolkit, Male couples, Sexual agreements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: Male Couples Agreement ProjectCouples 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. |
| Intervention group | Active comparator | Behavioral: Male Couples Agreement ProjectCouples 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
Key exclusion criteria (5 listed)
- 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.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
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 |
|---|---|---|
| Male Couples Agreement ProjectCouples 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. | Behavioural | Control group, Intervention group |
Primary outcome
Formation of a Sexual Agreement at 6 Months
Time frame: 6 month
Self-reports of yes/no to forming a sexual agreement via electronic survey
Adherence to a Sexual Agreement at 6 Months
Time frame: 6 month
Self-report of yes/no of adhering to a sexual agreement
6 secondary outcomes
Formation of a Sexual Agreement at 3 Months
Time frame: 3 month
Adherence to a Sexual Agreement
Time frame: 3 month
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Time frame: 3 month
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Time frame: month 6
Test for HIV During Past 3 Months (Months 0-3)
Time frame: 3 month
Test for HIV During the Last 3 Months (Months 3-6)
Time frame: month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32044754Mitchell JW, Lee JY, Wu Y, Sullivan PS, Stephenson R. Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Feb 13;4(2):e16807. doi: 10.2196/16807.
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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.
Jason W Mitchell, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male Couples Agreement Project in people with HIV, run by University of Miami 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 8 inclusion and 5 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 16 Apr 2019. 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. Some participants in this study may receive a placebo. 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 16 Apr 2019). 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?
Formation of a Sexual Agreement at 6 Months (time frame: 6 month). 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 NCT02494817, 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 16 Apr 2019.