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Completed

NCT Number: NCT03774160

Community and Systems-level HIV Prevention in Peru

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.

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Key information

Conditions

HIV

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cayetano Heredia University

Lima, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generacion Actual

Behavioral

See description in arm description.

Other names: Mpowerment

Primary outcomes

  1. condomless anal sex

    Time frame: 37 months post-baseline

    condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire

  2. HIV testing ever

    Time frame: 37 months post-baseline

    if have ever tested for HIV

  3. HIV testing frequency

    Time frame: 37 months post-baseline

    frequency of HIV testing by report on questionnaire

Secondary outcomes

  1. If enrolled in care

    Time frame: 37 months post-baseline

    Has the person, after testing HIV+, enroll in care

  2. Seeking regular HIV care

    Time frame: 37 months post-baseline

    If have seen HIV provider recently by report on questionnaire

  3. Taking medications adherently

    Time frame: 37 months post-baseline

    If have missed any times of taking HIV medications by report on questionnaire

  4. If virally suppressed

    Time frame: 37 months post-baseline

    Has the person been told that he/she is virally suppressed

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Universidad Peruana Cayetano Heredia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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