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

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.
 
ClinicalTrials.gov Identifier: NCT03483857
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
ANOVA Health Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: Peer Navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Peer Navigation
Individuals assigned to the PN condition will be assigned to one of 10 PN case managers who will follow an SOP described for initial intake and follow up visits with each participant. Participants will be asked to provide contact information for themselves and up to 3 individuals whom study staff can contact in case they cannot make direct contact with the study participant assigned to PN. PN will meet with their clients at least once monthly to discuss treatment related issues including medication access, side effects, adherence, stigma or discrimination related to HIV or their taking ART medication, etc. Participants will have contact information for their assigned PN and may contact them for reasons related to their treatment between scheduled monthly visits if they choose. All visits with PN will be recorded by the PN. and participants who fail to attend up to 3 scheduled PN appointments will be considered LTFU for the intervention.
Behavioral: Peer Navigation
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.

No Intervention: Standard of Care
Individuals assigned to SOC will be referred directly to the NCHC/RLS staff for treatment initiation or continuation. At intake they will receive standard treatment information per MPDOH guidelines, as well as information about Anova's RLS and Health4Men clinical and psychosocial services available at the NCHC. They will receive monthly text message reminders from study staff to refill ART prescriptions, and a separate reminder in month 6 to schedule complete their 6-month clinical visit. Study staff will verify that participants have picked up medications and attended all scheduled clinical visits by means of chart review and data extraction. Per MPDOH guidelines, individuals who fail to collect medications 3 months in a row, or who fail to attend their 6-month HIV clinical follow-up appointment, will be considered non-engaged and lost to follow up (LTFU).



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   As this study focuses on men who have sex with men, only persons born male are included.
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03483857


Locations
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South Africa
Anova Health Institute
Nelspruit, Mpumalanga, South Africa
Sponsors and Collaborators
University of California, San Francisco
ANOVA Health Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Sheri Lippman, PhD University of California, San Francsico

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03483857    
Other Study ID Numbers: 1R34MH109395-01 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
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
Keywords provided by University of California, San Francisco:
Peer Navigation
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases