Addressing Mental Health and Medication Adherence Among MSM in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Medication adherence (ART)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Intervention Condition
The intervention involves four weekly individual sessions followed by four weekly group support sessions, focusing on themes from the individual sessions. Services will be provided by peer wellness coaches from the MSM community, who will undergo an intensive two-week training with role-play and feedback, followed by weekly supervision. All testing and treatment services are provided free through Aurum.
干预措施: WeCare (Behavioral)
Control Condition
The control group (Phase 3) will receive enhanced standard care which includes access to services offered at the POP INN Wellness Clinic including psychoeducation for all individuals who enroll in PrEP or ART services, free medication, enrollment in their standard drop-in Mpowerment support groups, as well as referrals to mental health services on request
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Medication adherence (ART)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Persistence(Baseline, 3 months, 6 months)
- Status neutral composite adherence(Baseline, Month 3, Month 6)
- Self Reported medication adherence(Baseline, Month 3, Month 6)