PMID- 32887558 OWN - NLM STAT- MEDLINE DCOM- 20210212 LR - 20230807 IS - 1471-2458 (Electronic) IS - 1471-2458 (Linking) VI - 20 IP - 1 DP - 2020 Sep 4 TI - A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial. PG - 1358 LID - 10.1186/s12889-020-09380-3 [doi] LID - 1358 AB - BACKGROUND: Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH. METHODS: This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling. RESULTS: Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36). CONCLUSIONS: YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016. FAU - Dow, Dorothy E AU - Dow DE AUID- ORCID: 0000-0002-9056-1025 AD - Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA. Dorothy.dow@duke.edu. AD - Duke Global Health Institute, Durham, NC, USA. Dorothy.dow@duke.edu. AD - Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Dorothy.dow@duke.edu. FAU - Mmbaga, Blandina T AU - Mmbaga BT AD - Duke Global Health Institute, Durham, NC, USA. AD - Kilimanjaro Christian Medical Centre, Moshi, Tanzania. FAU - Gallis, John A AU - Gallis JA AD - Duke Global Health Institute, Durham, NC, USA. AD - Duke University, Department of Biostatistics and Bioinformatics, Durham, NC, USA. FAU - Turner, Elizabeth L AU - Turner EL AD - Duke Global Health Institute, Durham, NC, USA. AD - Duke University, Department of Biostatistics and Bioinformatics, Durham, NC, USA. FAU - Gandhi, Monica AU - Gandhi M AD - University of California, San Francisco, USA. FAU - Cunningham, Coleen K AU - Cunningham CK AD - Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA. AD - Duke Global Health Institute, Durham, NC, USA. FAU - O'Donnell, Karen E AU - O'Donnell KE AD - Duke University, Center for Health Policy and Inequalities Research, Durham, NC, USA. AD - Center for Child and Family Health, Durham, NC, USA. LA - eng SI - ClinicalTrials.gov/NCT02888288 GR - K01 TW009985/TW/FIC NIH HHS/United States GR - K01TW009985/TW/FIC NIH HHS/United States GR - R37 AI098472/AI/NIAID NIH HHS/United States GR - P30 AI027763/AI/NIAID NIH HHS/United States GR - P30 AI064518/AI/NIAID NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial DEP - 20200904 PL - England TA - BMC Public Health JT - BMC public health JID - 100968562 RN - 0 (Anti-HIV Agents) SB - IM MH - Adolescent MH - Anti-HIV Agents/therapeutic use MH - Female MH - HIV Infections/*drug therapy/*psychology MH - Humans MH - Male MH - Medication Adherence MH - Mental Health Services MH - Pilot Projects MH - Self Report MH - Social Stigma MH - Social Support MH - Tanzania PMC - PMC7487650 OTO - NOTNLM OT - ART adherence OT - Adolescent OT - Africa OT - HIV OT - HIV RNA OT - Intervention OT - Mental health OT - Tanzania OT - Viral load OT - Young people COIS- Authors have no conflict of interest to declare. EDAT- 2020/09/06 06:00 MHDA- 2021/02/13 06:00 PMCR- 2020/09/04 CRDT- 2020/09/05 05:14 PHST- 2020/01/14 00:00 [received] PHST- 2020/08/12 00:00 [accepted] PHST- 2020/09/05 05:14 [entrez] PHST- 2020/09/06 06:00 [pubmed] PHST- 2021/02/13 06:00 [medline] PHST- 2020/09/04 00:00 [pmc-release] AID - 10.1186/s12889-020-09380-3 [pii] AID - 9380 [pii] AID - 10.1186/s12889-020-09380-3 [doi] PST - epublish SO - BMC Public Health. 2020 Sep 4;20(1):1358. doi: 10.1186/s12889-020-09380-3.