NCT03048838

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

3.9 years

First QC Date

February 3, 2017

Last Update Submit

May 17, 2019

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months post-intervention

Study Arms (2)

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.

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.

Behavioral: Wellness Promotion Intervention

Interventions

Risk reduction behavioral interventionBEHAVIORAL
Risk reduction behavioral intervention
Wellness Promotion InterventionBEHAVIORAL
Wellness Promotion Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEnrollment will be limited to Latinos males and their same-sex partners
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29622045DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Omar Martinez, JD

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Martinez, JD

CONTACT

786-208-4340tug29454@temple.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either risk-reduction group (Conectado Latinos en Parejas, CLP) or wellness-promotion (WP) control condition
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 9, 2017

Study Start

May 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)