CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 276 enrolled
Drug / intervention
Project YES! Youth Engaging for Successbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04115813
NCT04115813N/ACompleted
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Transitioning Adolescents to HIV Self-Management in Zambia (Known as: Project YES: Youth Engaging for Success)

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Oct 4, 2019·Updated Oct 7, 2019

In Brief

A clinical study evaluating Project YES! Youth Engaging for Success for HIV/AIDS. Completed, enrolled 276 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS
CountriesZambia
CollaboratorsUnited States Agency for International Development (USAID), Population Council, Arthur Davison Children's Hospital

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2019
Enrollment StartDec 15, 2017
Primary CompletionFeb 19, 2019
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.7 years ago

Interventions

Project YES! Youth Engaging for Successbehavioral

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.