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Completed

NCT Number: NCT06880172

Mental Health and Medication Adherence Among MSM in South Africa

The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Aurum Institute

Johannesburg, 2194, South Africa

About this study

Men who have sex with men (MSM) are at an increased risk of HIV infection and transmission, and MSM with depression or anxiety may have adherence to medication challenges. Development of an integrated mental health and adherence support intervention for MSM can be an effective strategy to improve both psychological outcomes and care continuum outcomes including adherence to Pre-Exposure prophylaxis (PrEP) and Anti Retroviral Therapy (ART).

The team proposes developing an intervention approach that responds to the unique social contexts of South African MSM living with or at risk for HIV, and that addresses the relationship between mental health and adherence to HIV prevention medication (daily PrEP) and ART. This intervention approach, WeCare, will adapt an evidence-based program entitled Friendship Bench (i.e., FB) - an empirically supported mental health program using problem-solving therapy (developed/validated in southern Africa) - to incorporate mental health and medication adherence concerns for MSM.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cis-gender male
  • Reside in the Johannesburg metropolitan area with no plans to relocate during the next 6 months
  • Current prescription for any ART regimen (HIV-positive participants) or daily oral PrEP (HIV-negative participants) at the POP INN clinic
  • Self-reported challenges adhering to daily ART (HIV-positive participants) or PrEP (HIV-negative participants)
  • Interested in participating in a group discussion to discuss common mental health problems and medication adherence challenges
  • Ability to understand and provide informed consent.

Exclusion criteria

  • Presently engaged in mental health therapy.
  • Participated as an intervention participant in a pilot mental health study (AUR6-8-403)
  • Refuses audio recording of the focus group discussion
  • Those who score over 20 on the PHQ-9 (i.e., indicating severe depression)

Treatment and study plan

WeCare

Behavioral

Individual level: Problem identification, Linking Mental health and minority stress, medication adherence, developing an action plan, complementing the plan, and follow-up.

Group level: Social support and self acceptance in MSM, coping with stigma and minority stress, support for medication adherence

Standard of Care

Behavioral

Access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, and enrollment in their standard drop-in. Mpowerment support groups, as well as referrals to mental health services on request

Primary outcomes

  1. Medication adherence (ART)

    Time frame: Baseline, Month 3, Month 6

    ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load <200 copies/mL) in the blood sample

  2. Medication adherence (PrEP)

    Time frame: Baseline, Month 3, Month 6

    PrEP adherence is defined as an intracellular TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample

  3. Mental health status

    Time frame: Baseline, Month 3, Month 6

    Patient Health Questionnaire (PHQ-9) measures the frequency of depression symptoms within the past two weeks. The PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms.

  4. Psychological stress

    Time frame: Baseline, Month 3, Month 6

    The WHO Self-Reporting Questionnaire-20 (SRQ-20) will be used that includes items to reflect symptoms of depression, anxiety and psychosomatic complaints, which are all together grouped under the heading of common mental disorder (CMD).

Secondary outcomes

  1. Status neutral composite adherence

    Time frame: Baseline, Month 3, Month 6

    This is based on TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample OR HIV-1 RNA viral load <200 copies/mL)

  2. Self Reported medication adherence

    Time frame: Baseline, Month 3, Month 6

    participants will be asked, "How many days did you not take your PrEP [ART] in the past 30 days (0-30 days)

  3. Persistence

    Time frame: Baseline, 3 months, 6 months

    Defined as time to first PrEP discontinuation, based on a PrEP clinical hold, elective PrEP stop, or missed prescription refill as indicated by pharmacy data

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Addressing Mental Health and Medication Adherence Among MSM in South Africa

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 10, 2026

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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