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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Peer Support

• Registration Number: NCT02833441
• Lead Sponsor: University of Zimbabwe

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.

Detailed Description

Title The Peer Support Intervention - supporting HIV positive adolescents in Zimbabwe to improve HIV care continuum outcomes

Short Title The Peer Support Intervention

Study Design Prospective randomized study

Study Duration 2 years

Study Population 250 Youth (ages 10-24 years) with virologic failure

Study Outcomes Primary Outcomes

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

Secondary Outcomes

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

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

3. 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

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

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

Description of Intervention 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.

Study Sites Parirenyatwa Hospital Family Care Centre

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Support Intervention	Peer Support	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.

Primary Outcome Measures

Name	Time	Method
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.	2 years	Virologic suppression

Secondary Outcome Measures

Name	Time	Method
Frequency of acquired drug resistance mutations among youth failing ART.	2 years	drug resistance mutations
Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy	2 years	psychological distress
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	psychological distress
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	(viral load), DBS and hair (tenofovir concentrations).
Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.	2 years	detection of drug resistance

Trial Locations

Locations (1)

Parirenyatwa Hospital; 🇿🇼 Harare, Zimbabwe