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Trial record 30 of 1405 for:    Peru

Community and Systems-level HIV Prevention in Peru

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03774160
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Cayetano Heredia University, Lima, Peru
Information provided by (Responsible Party):
Susan Kegeles, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Generacion Actual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: Mpowerment

No Intervention: Comparison
No intervention is implemented in the comparison arm.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03774160

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Cayetano Heredia University
Lima, Peru
Sponsors and Collaborators
University of California, San Francisco
Cayetano Heredia University, Lima, Peru
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Principal Investigator: Susan M Kegeles, PhD University of California, San Francisco

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Responsible Party: Susan Kegeles, Professor of Medicine, University of California, San Francisco Identifier: NCT03774160     History of Changes
Other Study ID Numbers: 5R01MH109401-04 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No