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Community and Systems-level HIV Prevention in Peru

Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03774160
Enrollment
458
Registered
2018-12-12
Start date
2017-04-06
Completion date
2021-01-30
Last updated
2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

BEHAVIORALGeneracion Actual

See description in arm description.

Sponsors

Universidad Peruana Cayetano Heredia
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
condomless anal sex37 months post-baselinecondomless anal sex with HIV+ or unknown status partners, assessed via questionnaire
HIV testing ever37 months post-baselineif have ever tested for HIV
HIV testing frequency37 months post-baselinefrequency of HIV testing by report on questionnaire

Secondary

MeasureTime frameDescription
If enrolled in care37 months post-baselineHas the person, after testing HIV+, enroll in care
If virally suppressed37 months post-baselineHas the person been told that he/she is virally suppressed
Seeking regular HIV care37 months post-baselineIf have seen HIV provider recently by report on questionnaire
Taking medications adherently37 months post-baselineIf have missed any times of taking HIV medications by report on questionnaire

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026