HIV
Conditions
Keywords
MSM, PrEP, ART
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALWeCare
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
BEHAVIORALStandard of Care
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
Sponsors
Emory University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence (ART) | 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 |
| Medication adherence (PrEP) | 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 |
| Mental health status | 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. |
| Psychological stress | 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
| Measure | Time frame | Description |
|---|---|---|
| Status neutral composite adherence | 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) |
| Self Reported medication adherence | 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) |
| Persistence | 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 |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORJacqueline Pienaar
The Aurum Institute, Johannesburg
Outcome results
None listed