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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
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
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
The Aurum Institute
Johannesburg, South Africa
Medication adherence (ART)
ART adherence will be defined as a suppressed HIV viral load (HIV-1 RNA viral load \<200 copies/mL) in the blood sample
Time frame: Baseline, Month 3, Month 6
Medication adherence (PrEP)
PrEP adherence is defined as an intracellular TFV-DP concentration ≥700 fmol/punch in a dried blood spot (DBS) sample
Time frame: Baseline, Month 3, Month 6
Mental health status
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.
Time frame: Baseline, Month 3, Month 6
Psychological stress
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).
Time frame: Baseline, Month 3, Month 6
Status neutral composite adherence
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)
Time frame: Baseline, Month 3, Month 6
Self Reported medication adherence
participants will be asked, "How many days did you not take your PrEP \[ART\] in the past 30 days (0-30 days)
Time frame: Baseline, Month 3, Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Persistence
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
Time frame: Baseline, 3 months, 6 months