HIV/AIDSNCT03048838
A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
A study testing Risk reduction behavioral intervention and Wellness Promotion Intervention in people with HIV/AIDS, run by Temple University at 1 site in United States.
Trial summary
Epidemiological studies have attributed the source of many new HIV and STI infections among MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious interventions for Latino male couples have yet to be tested. 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/AIDS
- What is being tested?
- Risk reduction behavioral intervention and Wellness Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2020
- Phase
- Interventional
- 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
- be at least 18 years old;
- report having a main/primary male partner during the past 90 days (operationalized as a man with whom he has had a sexual relationship during the past 90 days and has a strong emotional bond);
- self-identify as Latino/Hispanic or identify as having a main partner who identifies as Latino/Hispanic;
- reports sexual activity in the past 90 days as described in the screening instrument;
- identify each other as their main partner;
- able to speak English and/or Spanish;
- plan to remain in the area for the next 8 months.
Who cannot join
- Couples will be excluded if:
- either partner reports that participating in a study that talks about sex, relationship issues and alcohol/drugs will put him in danger;
- either partner has a language or cognitive impairment that would prevent comprehension of study procedures;
- either partner is currently on PrEP and fully adherent, or enrolled in any other HIV prevention study;
- either partner is planning to move outside the area in the next 8 months;
- either partner is planning on ending the relationship with his partner in the next 8 months; and
- either partner reports being in a stable triadic relationship (operationalized as a relationship in which all 3 men have a strong emotional bond and the 3 men are having sex with each other).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
Omar Martinez, JD, 786-208-4340, tug29454@temple.edu
Omar Valentin, MPH, omar.valentin@temple.edu
About this study
Epidemiological studies have attributed the source of many new HIV and STI infections among MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious interventions for Latino male couples have yet to be tested. The proposed study builds on the PI's post-doctoral research in which he adapted evidence based intervention for Black MSM couples, Connect 'n Unite, for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV testing if appropriate given the couple's serostatus. The investigators will conduct a randomized control trial (RCT) to examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts (operationalized as using condoms, PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA and randomly assign them to CLP or WP. Participants will complete ACASIs to assess behavioral and psychosocial factors and be tested for sexually transmitted infections (STI) at baseline, 3 and 6 month post intervention. The investigators will conduct optional HIV/STI testing at baseline, 3, and 6 month post intervention. The primary study activities will be conducted at a large Latino serving CBO in North Philadelphia. To our knowledge, this study will be the first to examine the impact of a couple-based intervention to increase HIV protected anal sex acts for Latino male couples capable of being scaled up and replicated in various communities to provide continuous support and protection for this heavily impacted group.
Read the detailed description
Latino men who have sex with men (MSM) continue to be disproportionately affected by HIV. Experiences of stigma, discrimination, marginalization, sexual objectification, negative cultural perceptions of homosexuality, and cultural values such as 'familismo' and 'machismo' elevate their vulnerability to HIV infection. Many Latino MSM use substances as a way to cope with or alleviate these stressors, further increasing their risk. Although efficacious interventions for Latino MSM have been developed, not a single one has focused on Latino male couples, despite strong evidence from White MSM that HIV infection often occurs within primary couple relationships. Findings from the investigators formative study with Latino MSM suggest that the factors driving HIV risk for White male couples also operate among Latino male couples. For instance, Latino men in male couples were more likely to report condomless anal sex and problematic alcohol use than those who were not in a relationship. Developing and testing tailored interventions for Latino male couples, as the investigators are proposing, is warranted.
The proposed study builds on the PI's post-doctoral research which adapted an evidence based intervention for Black MSM couples, Connect 'n Unite (CNU), for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectando Latinos en Pareja (CLP), expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP); promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) for HIV-positive individuals and/or couples; and encouraging routine HIV testing, if appropriate given the couple's serostatus. The investigators have proposed a two-phase study to determine the preliminary efficacy of Conectando Latinos en Pareja to increase the proportion of anal sex acts that are HIV protected (i.e. anal sex acts in which condoms, PrEP, TasP, or combination thereof reduce risk of HIV transmission). During Phase 1, the investigators will develop and finalize the intervention manuals and assessment instruments, pilot test the intervention, and conduct the necessary preparatory activities for launching a randomized control trial (RCT). During Phase 2, the investigators will conduct a RCT to examine whether participants assigned to CLP report an increase in the proportion of HIV-protected anal sex acts compared to those assigned to a Wellness Promotion (WP), a time-matched attention control (the investigators will use an algorithm that incorporates use of condoms, PrEP, and/or TasP, depending on the serostatus of the couple to compute the dependent variable).
The investigators will recruit 150 Latino male couples (where at least one member of the dyad self-identifies as Latino) in the corridor between Philadelphia, PA and Trenton, NJ - an area with porous borders where many diverse subgroups of Latinos live. The investigators will randomly assign couples to CLP or WP. The investigators will assess sexual, alcohol and drug use behaviors and other psychosocial factors (e.g., depressive symptoms, anxiety symptoms) at baseline, 3, and 6 months post-intervention. Participants who consent to optional HIV/STI testing will be tested for HIV, chlamydia, and gonorrhea at baseline and at 3 and 6 months post-intervention. The primary assessment and project management activities will be conducted at GALAEI, a large Latino-serving CBO in North Philadelphia. Recruitment and screening will be done at community and internet venues. Intervention activities will be conduct at GALAEI, Temple University, and other safe spaces convenient to study participants.
- Conditions
- HIV/AIDS
- Being tested
- Risk reduction behavioral intervention, Wellness Promotion Intervention
- 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.
Risk reduction behavioral interventionBehavioural
Wellness Promotion InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Risk reduction behavioral intervention | Experimental | Couples randomized to the risk reduction behavioral intervention ("Conectando Latinos en Pareja") will participate in four weekly sessions with a facilitator. Each session will last 2 hours. Participants will receive information and complete activities, participate in games and discussions to improve their relationship and improve health. Receives: Behavioral: Risk reduction behavioral intervention |
| Wellness Promotion Intervention | Active comparator | Couples randomized to the wellness promotion control group will receive the same number of hours of attention as the active experimental group but will not receive the risk reduction intervention. Information presented will consist of topics related to general health. Receives: Behavioral: Wellness Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of HIV protected anal sex acts between baseline and six months
Change in proportion of anal sex acts involving protective measures (condoms, PrEP, TasP) to reduce risk of HIV transmission between baseline and six months
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startMay 2016
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be assigned to either risk-reduction group (Conectado Latinos en Parejas, CLP) or wellness-promotion (WP) control condition
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Columbia University, Nova Southeastern University
- Responsible party
- Sponsor
- Investigators
- Omar Martinez, JD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048838
- Sponsor's protocol ID
- 24120
- Status last verified
- May 2019
- First submitted
- 3 Feb 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez O, Isabel Fernandez M, Wu E, Carballo-Dieguez A, Prado G, Davey A, Levine E, Mattera B, Lopez N, Valentin O, Murray A, Sutton M. A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial. Trials. 2018 Apr 5;19(1):218. doi: 10.1186/s13063-018-2582-y.
PubMed 29622045
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couple-based HIV Prevention Intervention to Promote HIV Protection Among Latino Male Couples
- ClinicalTrials.gov ID
- NCT03048838
- Acronym / sponsor ID
- 24120
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Columbia University, Nova Southeastern University
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Epidemiological studies have attributed the source of many new HIV and STI infections among MSM to primary partners. Despite recent emphasis on couples-based interventions, efficacious interventions for Latino male couples have yet to be tested. The proposed study builds on the PI's post-doctoral research in which he adapted evidence based intervention for Black MSM couples, Connect 'n Unite, for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectado Latinos en Parejas (CLP) expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP), promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) and encouraging routine HIV testing if appropriate given the couple's serostatus. The investigators will conduct a randomized control trial (RCT) to examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts (operationalized as using condoms, PrEP, TasP) compared to those assigned to a Wellness Promotion (WP) time matched attention control. The investigators will recruit 150 Latino male couples from the Philadelphia MSA and randomly assign them to CLP or WP. Participants will complete ACASIs to assess behavioral and psychosocial factors and be tested for sexually transmitted infections (STI) at baseline, 3 and 6 month post intervention. The investigators will conduct optional HIV/STI testing at baseline, 3, and 6 month post intervention. The primary study activities will be conducted at a large Latino serving CBO in North Philadelphia. To our knowledge, this study will be the first to examine the impact of a couple-based intervention to increase HIV protected anal sex acts for Latino male couples capable of being scaled up and replicated in various communities to provide continuous support and protection for this heavily impacted group.
Detailed description
Latino men who have sex with men (MSM) continue to be disproportionately affected by HIV. Experiences of stigma, discrimination, marginalization, sexual objectification, negative cultural perceptions of homosexuality, and cultural values such as 'familismo' and 'machismo' elevate their vulnerability to HIV infection. Many Latino MSM use substances as a way to cope with or alleviate these stressors, further increasing their risk. Although efficacious interventions for Latino MSM have been developed, not a single one has focused on Latino male couples, despite strong evidence from White MSM that HIV infection often occurs within primary couple relationships. Findings from the investigators formative study with Latino MSM suggest that the factors driving HIV risk for White male couples also operate among Latino male couples. For instance, Latino men in male couples were more likely to report condomless anal sex and problematic alcohol use than those who were not in a relationship. Developing and testing tailored interventions for Latino male couples, as the investigators are proposing, is warranted.
The proposed study builds on the PI's post-doctoral research which adapted an evidence based intervention for Black MSM couples, Connect 'n Unite (CNU), for Latino male couples using methodologically rigorous adaptation procedures. The adapted intervention, Conectando Latinos en Pareja (CLP), expands the prevention alternatives offered in previous interventions by incorporating biomedical prevention methods such as pre-exposure prophylaxis (PrEP); promoting engagement in care, adherence to treatment regimens and viral suppression (TasP) for HIV-positive individuals and/or couples; and encouraging routine HIV testing, if appropriate given the couple's serostatus. The investigators have proposed a two-phase study to determine the preliminary efficacy of Conectando Latinos en Pareja to increase the proportion of anal sex acts that are HIV protected (i.e. anal sex acts in which condoms, PrEP, TasP, or combination thereof reduce risk of HIV transmission). During Phase 1, the investigators will develop and finalize the intervention manuals and assessment instruments, pilot test the intervention, and conduct the necessary preparatory activities for launching a randomized control trial (RCT). During Phase 2, the investigators will conduct a RCT to examine whether participants assigned to CLP report an increase in the proportion of HIV-protected anal sex acts compared to those assigned to a Wellness Promotion (WP), a time-matched attention control (the investigators will use an algorithm that incorporates use of condoms, PrEP, and/or TasP, depending on the serostatus of the couple to compute the dependent variable).
The investigators will recruit 150 Latino male couples (where at least one member of the dyad self-identifies as Latino) in the corridor between Philadelphia, PA and Trenton, NJ - an area with porous borders where many diverse subgroups of Latinos live. The investigators will randomly assign couples to CLP or WP. The investigators will assess sexual, alcohol and drug use behaviors and other psychosocial factors (e.g., depressive symptoms, anxiety symptoms) at baseline, 3, and 6 months post-intervention. Participants who consent to optional HIV/STI testing will be tested for HIV, chlamydia, and gonorrhea at baseline and at 3 and 6 months post-intervention. The primary assessment and project management activities will be conducted at GALAEI, a large Latino-serving CBO in North Philadelphia. Recruitment and screening will be done at community and internet venues. Intervention activities will be conduct at GALAEI, Temple University, and other safe spaces convenient to study participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either risk-reduction group (Conectado Latinos en Parejas, CLP) or wellness-promotion (WP) control condition
| Arm | Type | Receives |
|---|---|---|
| Risk reduction behavioral intervention | Experimental | Behavioral: Risk reduction behavioral interventionCouples randomized to the risk reduction behavioral intervention ("Conectando Latinos en Pareja") will participate in four weekly sessions with a facilitator. Each session will last 2 hours. Participants will receive information and complete activities, participate in games and discussions to improve their relationship and improve health. |
| Wellness Promotion Intervention | Active comparator | Behavioral: Wellness Promotion InterventionCouples randomized to the wellness promotion control group will receive the same number of hours of attention as the active experimental group but will not receive the risk reduction intervention. Information presented will consist of topics related to general health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be at least 18 years old;
- report having a main/primary male partner during the past 90 days (operationalized as a man with whom he has had a sexual relationship during the past 90 days and has a strong emotional bond);
- self-identify as Latino/Hispanic or identify as having a main partner who identifies as Latino/Hispanic;
- reports sexual activity in the past 90 days as described in the screening instrument;
- identify each other as their main partner;
Key exclusion criteria (7 listed)
- either partner reports that participating in a study that talks about sex, relationship issues and alcohol/drugs will put him in danger;
- either partner has a language or cognitive impairment that would prevent comprehension of study procedures;
- either partner is currently on PrEP and fully adherent, or enrolled in any other HIV prevention study;
- either partner is planning to move outside the area in the next 8 months;
- either partner is planning on ending the relationship with his partner in the next 8 months; and
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 |
|---|---|---|
| Risk reduction behavioral intervention | Behavioural | Risk reduction behavioral intervention |
| Wellness Promotion Intervention | Behavioural | Wellness Promotion Intervention |
Primary outcome
Change in proportion of HIV protected anal sex acts between baseline and six months
Time frame: 6 months post-intervention
Change in proportion of anal sex acts involving protective measures (condoms, PrEP, TasP) to reduce risk of HIV transmission between baseline and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 29622045Martinez O, Isabel Fernandez M, Wu E, Carballo-Dieguez A, Prado G, Davey A, Levine E, Mattera B, Lopez N, Valentin O, Murray A, Sutton M. A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial. Trials. 2018 Apr 5;19(1):218. doi: 10.1186/s13063-018-2582-y.
- 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.
Omar Martinez, JD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk reduction behavioral intervention and Wellness Promotion Intervention in people with HIV/AIDS, run by Temple 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Martinez, JD (786-208-4340, tug29454@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of HIV protected anal sex acts between baseline and six months (time frame: 6 months post-intervention). 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 NCT03048838, 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 21 May 2019.