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Completed

NCT Number: NCT03483857

Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa

This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Anova Health Institute

Mbombela, Mpumalanga, South Africa

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Biological male;
  • Age >=18 years;
  • Self-identify as a gay or bisexual man, or a transgender woman;
  • Have male sexual partners within the prior six months
  • Resident in the Ehlanzeni District Municipality for at least six months of the year;
  • Be physically present in Ehlanzeni for at least two weeks per month
  • Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
  • Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
  • Consent for study staff to review participants' clinical records;
  • Consent to the randomization process.

Exclusion criteria

  • Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
  • Inability to provide laboratory or documentary evidence of HIV diagnosis.

Treatment and study plan

Peer navigation

Behavioral

Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.

Primary outcomes

  1. Viral Suppression

    Time frame: 6 months

    The proportion of participants virally suppressed (HIV RNA <1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • ANOVA Health Institute
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Feb 5, 2020

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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