Clinical trial NCT03774160: Community and Systems-level HIV Prevention in Peru
Official title: Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
First posted: 2018-12-12
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different districts are being used, one in which the intervention is implemented and the other is a no-intervention comparison site.
Primary purpose: PREVENTION

Brief summary: This project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote HIV prevention and sexual health among men who have sex with men and transgender women in Lima, Peru. The total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with HIV get care and medications.

Detailed description: Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention for young men who have sex with men (MSM). MP targets individual and community empowerment and community mobilization, self-affirmation, sexual self-knowledge and creation of a supportive and affirming social environment. MP has been widely used in the U.S. but not in Peru, with the exception of earlier pilot research. In the earlier research, MP was adapted for the sociocultural issues facing MSM and transgender (trans) women in Peru, and only focused risk reduction and increasing HIV testing. In addition to the MP (which is called the community-based intervention), a health systems component has been added. The health systems includes (1) sensitization of hospital staff (where people living with HIV obtain their medication) to the issues facing transgender women and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the system of care and remain in care; and (3) a focus on "positive prevention", in which providers talk about the positive aspects of maintaining in care and being virally suppressed instead of only talking about "avoiding death." There is a 2.5 year implementation of the intervention, called "Projecto Orgullo Plus" or Project Pride Plus, which involves a longitudinal cohort of MSM/trans in two large districts of Lima, Peru. Primary outcomes will be unprotected anal sex and HIV testing. Secondary outcomes will be self-reported visits to hospital for care and adherence to medications.

Eligibility criteria: Inclusion Criteria:

* Must live in either East Lima District or South Lima District
* identify as man who has sex with men or transgender woman who has sex with men
* be between the ages of 18 - 40

Exclusion Criteria:

* not residing in either East or South District of Lima
* not MSM or transgender woman

Primary outcomes:
measure: condomless anal sex
timeFrame: 37 months post-baseline
measure: HIV testing ever
timeFrame: 37 months post-baseline
measure: HIV testing frequency
timeFrame: 37 months post-baseline
Secondary outcomes:
measure: If enrolled in care
timeFrame: 37 months post-baseline
measure: Seeking regular HIV care
timeFrame: 37 months post-baseline
measure: Taking medications adherently
timeFrame: 37 months post-baseline
measure: If virally suppressed
timeFrame: 37 months post-baseline
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Cayetano Heredia University
Study officials:
affiliation: University of California, San Francisco
name: Susan M Kegeles, PhD
role: PRINCIPAL_INVESTIGATOR
References: