The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

NCT02833441 | Completed

• 2 other identifiers: Peer Support InterventionNo. AID-OAA-A-14-00046
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

Youth with evidence of virologic failure defined as an HIV VL\>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Virologic suppression rate in the Peer Support Intervention i group compared with the standard of care group following 48 weeks in the Peer Support Intervention.

  Virologic suppression

  2 years

Secondary Outcomes (5)

• Frequency of acquired drug resistance mutations among youth failing ART.

  2 years

• Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy

  2 years

• Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care

  2 years

• Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).

  2 years

• Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.

  2 years

Study Arms (2)

Peer Support Intervention

EXPERIMENTAL

Adolescents/young adults in the Peer Support Intervention arm will be referred to a Peer Support Intervention support group within their own or nearby community. This support group will meet monthly and will be facilitated by a professional HIV counsellor together with a Peer Support Intervention counselor. The Peer Support Intervention counsellors will provide regular counselling to their allocated participants through home visits and SMS messages. Each participant will be visited once a week in their home. Whatsapp messages will be delivered daily to each participant by the Community Adolescent Treatment Supporters. The agreed messages will briefly enquire about the participant's well-being without specifically making reference to HIV or ARVs. In addition, participants' caregivers will be invited to a 3-session intervention to build knowledge, skills and confidence to better support their adolescents.

Behavioral: Peer Support

Standard of Care Practice

NO INTERVENTION

Participants in the standard of care group will receive adherence evaluations and counseling at the clinic as per the current standard of care. Current procedures involve a group counseling session given on Monday morning during which topics are discussed that are relevant to adolescents. In general children aged between 13-19 years attend these sessions. After the group counseling, adolescents also receive an individual counseling session before being evaluated by the clinic doctor. Youth are also encouraged to complete a self reported adherence questionnaire and may periodically undergo pill counts by the clinic counselors. The adolescents may belong to peer support groups in their communities, however these activities are not part of the clinic program. No interventions are typically targeted at their caregivers.

Interventions

Peer Support BEHAVIORAL

Peer Support Intervention

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Documented HIV positive
• Age \> 10 years and ≤ 24 years
• Two consecutive HIV VL\>400 copies/mL, at least one month apart
• Residence within 50 km of Harare
• Able to provide written informed consent (age 18 or older) or assent (age \<18 years)

You may not qualify if:

• Inability to provide informed consent or assent
• Past or current involvement in the Zvandiri Intervention Program

Sponsors & Collaborators

• University of Zimbabwe: lead

Study Sites (1)

Parirenyatwa Hospital

Harare, 00263, Zimbabwe

Location

Related Publications (2)

• Mtisi TJ, Kouamou V, Morse GD, Dzinamarira T, Ndhlovu CE. Comparing pill counts and patient self-reports versus DBS tenofovir concentrations as ART adherence measurements with virologic outcomes and HIV drug resistance in a cohort of adolescents and young adults failing ART in Harare, Zimbabwe. J Infect Public Health. 2024 Sep;17(9):102500. doi: 10.1016/j.jiph.2024.102500. Epub 2024 Jul 17.

  PMID: 39173560 DERIVED

• Ndhlovu CE, Kouamou V, Nyamayaro P, Dougherty L, Willis N, Ojikutu BO, Makadzange AT. The transient effect of a peer support intervention to improve adherence among adolescents and young adults failing antiretroviral therapy in Harare, Zimbabwe: a randomized control trial. AIDS Res Ther. 2021 Jun 16;18(1):32. doi: 10.1186/s12981-021-00356-w.

  PMID: 34134738 DERIVED

Study Officials

• Chiratidzo E Ndhlovu, MBChB

  University of Zimbabwe College of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)