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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Peer Support
Sponsored by
University of Zimbabwe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV

Eligibility Criteria

10 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parirenyatwa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Support Intervention

Standard of Care Practice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2016
Last Updated
October 12, 2018
Sponsor
University of Zimbabwe
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1. Study Identification

Unique Protocol Identification Number
NCT02833441
Brief Title
The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Acronym
PESU
Official Title
The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zimbabwe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Frequency of acquired drug resistance mutations among youth failing ART. Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy 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 Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations). 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Support Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Practice
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Support
Primary Outcome Measure Information:
Title
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.
Description
Virologic suppression
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Frequency of acquired drug resistance mutations among youth failing ART.
Description
drug resistance mutations
Time Frame
2 years
Title
Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy
Description
psychological distress
Time Frame
2 years
Title
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
Description
psychological distress
Time Frame
2 years
Title
Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).
Description
(viral load), DBS and hair (tenofovir concentrations).
Time Frame
2 years
Title
Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.
Description
detection of drug resistance
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiratidzo E Ndhlovu, MBChB
Organizational Affiliation
University of Zimbabwe College of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parirenyatwa Hospital
City
Harare
ZIP/Postal Code
00263
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is readily available and can be obtained following review by MRCZ as required in the consent forms.
Citations:
PubMed Identifier
34134738
Citation
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.
Results Reference
derived

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

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