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Completed

NCT Number: NCT02833441

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

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.

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Key information

Conditions

HIV

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parirenyatwa Hospital

Harare, 00263, Zimbabwe

About this study

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

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Support

Behavioral

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.

    Time frame: 2 years

    Virologic suppression

Secondary outcomes

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

    Time frame: 2 years

    drug resistance mutations

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

    Time frame: 2 years

    psychological distress

  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

    Time frame: 2 years

    psychological distress

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

    Time frame: 2 years

    (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.

    Time frame: 2 years

    detection of drug resistance

Sponsors and collaborators

Lead sponsor

University of Zimbabwe

Other

Registry information

Acronym: PESU

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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