MedTrace Logo

Project YES! Youth Engaging for Success

NCT04115813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2019-10-07

No results posted yet for this study

Summary

Youth-led strategies remain untested in clinic-based programs to achieve viral suppression (VS) and reduce self-stigma (feelings of worthlessness/shame) among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa. In response, Project YES! will conduct a randomized controlled trial to test the impact of a theory-based intervention that places trained and paid HIV-positive youth peer mentors (YPMs) in four HIV clinics in Ndola, Zambia. AYA, ages 15 to 24 years, will be randomly assigned to either an intervention arm, consisting of monthly one-on-one and small group sessions with a YPM and optional caregiver support groups, or a usual care arm. Survey data and blood samples will be collected and analyzed to test the hypothesis that youth who are in the intervention group will experience more viral suppression than youth in the comparison group.

Conditions

Interventions

BEHAVIORAL

Project YES! Youth Engaging for Success

Participants in the intervention were offered once a month one-on-one meetings and group meetings with their assigned youth peer mentors over approximately six months. The participant's caregiver could also attend up to 3 caregiver support groups held at the clinic (every other month). In addition, intervention participants in the children's hospital were assessed (clinical and psycho social factors) for physical transition to an adult clinic. After midline data collection, the intervention arm went into a maintenance phase, meeting with the youth peer mentor every other month (3 times). Participants in the comparison arm after midline started the Project YES! intervention as described above. Primary analysis was conducted using midline data.

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Population Council

    collaborator OTHER

  • Arthur Davison Children's Hospital

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Julie A Denison, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-02-19
Completion
2019-06-20

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115813 on ClinicalTrials.gov