Community and Systems-level HIV Prevention in Peru

NCT03774160 | Completed

• 1 other identifier: 5R01MH109401-04
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• If enrolled in care

  37 months post-baseline

• Seeking regular HIV care

  37 months post-baseline

• Taking medications adherently

  37 months post-baseline

• If virally suppressed

  37 months post-baseline

Study Arms (2)

Generacion Actual

EXPERIMENTAL

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

Comparison

NO INTERVENTION

No intervention is implemented in the comparison arm.

Interventions

Generacion Actual BEHAVIORAL

See description in arm description.

Also known as: Mpowerment

Generacion Actual

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Universidad Peruana Cayetano Heredia: collaborator

Study Sites (1)

Cayetano Heredia University

Lima, Peru

Location

Study Officials

• Susan M Kegeles, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two different districts are being used, one in which the intervention is implemented and the other is a no-intervention comparison site.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 12, 2018
• Study Start: April 6, 2017
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)