Community and Systems-level HIV Prevention in Peru

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Generacion Actual

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.

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • Cayetano Heredia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Generacion Actual; Generacion Actual includes Community-based and a Health Systems Components. This multi-level intervention reaches out to all MSM/trans by mobilizing them to encourage friends to reduce risk behavior and increase HIV testing, and for HIV+ friends, encourage them to link, stay in care, and take medications regularly. The community based component includes a leadership group, community space, community mobilization events, and group sessions to address a variety of psychosocial issues as well as HIV literacy. The Health Systems component includes sensitization of the HIV testing and care staff to working with MSM and trans, Navigators to help MSM/trans to navigate the complex health system; and positive prevention training of providers; all evidence-based approaches.	Behavioral: Generacion Actual; See description in arm description.; Other Names: Mpowerment
No Intervention: Comparison; No intervention is implemented in the comparison arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
condomless anal sex	condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire	37 months post-baseline
HIV testing ever	if have ever tested for HIV	37 months post-baseline
HIV testing frequency	frequency of HIV testing by report on questionnaire	37 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If enrolled in care	Has the person, after testing HIV+, enroll in care	37 months post-baseline
Seeking regular HIV care	If have seen HIV provider recently by report on questionnaire	37 months post-baseline
Taking medications adherently	If have missed any times of taking HIV medications by report on questionnaire	37 months post-baseline
If virally suppressed	Has the person been told that he/she is virally suppressed	37 months post-baseline

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Susan M Kegeles, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 5R01MH109401-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No