Community and Systems-level HIV Prevention in Peru

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774160
• Other study ID #: 5R01MH109401-04
• Status: Completed
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: April 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Generacion Actual
See description in arm description.

Locations

Country	Name	City	State
Peru	Cayetano Heredia University	Lima

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	condomless anal sex	condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire	37 months post-baseline
Primary	HIV testing ever	if have ever tested for HIV	37 months post-baseline
Primary	HIV testing frequency	frequency of HIV testing by report on questionnaire	37 months post-baseline
Secondary	If enrolled in care	Has the person, after testing HIV+, enroll in care	37 months post-baseline
Secondary	Seeking regular HIV care	If have seen HIV provider recently by report on questionnaire	37 months post-baseline
Secondary	Taking medications adherently	If have missed any times of taking HIV medications by report on questionnaire	37 months post-baseline
Secondary	If virally suppressed	Has the person been told that he/she is virally suppressed	37 months post-baseline