Project YES! Youth Engaging for Success

NCT04115813 | Completed

• 1 other identifier: IRB00007870
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Keywords

Adolescents; Young Adults; Antiretroviral Therapy; Caregivers; Support Groups

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Viral Suppression (<1000 copies/mL) at Baseline and Midline

  \<1000 copies/mL

  ~ 6 months (from baseline to midline)

Secondary Outcomes (2)

• Proportion of Participants with Internalized Stigma (binary, yes to two out of three questions) at baseline and midline.

  ~ 6 months (from baseline to midline)

• Proportion of Participants with Antiretroviral Adherence Treatment Gap at baseline and midline

  ~ 6 months (from baseline to midline)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm participants received the Project YES! intervention for the first phase and then after midline data collection went into a maintenance phase.

Behavioral: Project YES! Youth Engaging for Success

Comparison Arm

OTHER

The comparison arm was a usual care arm during the first phase (and primary analysis). After midline data collection the comparison arm began receiving the Project YES! intervention.

Behavioral: Project YES! Youth Engaging for Success

Interventions

Project YES! Youth Engaging for Success BEHAVIORAL

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.

Comparison Arm; Intervention Arm

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In the age range of 15-24 years
• Aware of her/his HIV status
• On cART for at least six months
• Speaks Bemba or English
• Not planning to move out of the district in the next 18 months
• Planning to be available to attend study activities over the next 18-months, as needed

You may not qualify if:

• Being too sick to participate
• Attending boarding school
• Having a sibling already enrolled in the study (one youth per household)
• Having participated in the recent NIH-funded R34 Positive Connections intervention

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• United States Agency for International Development (USAID): collaborator
• Population Council: collaborator
• Arthur Davison Children's Hospital: collaborator

Study Sites (1)

Arthur Davison Children's Hospital

Ndola, Copperbelt, Zambia

Location

Related Publications (22)

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• Merrill KG, Campbell JC, Kennedy CE, Burke VM, Miti S, Frimpong C, Decker MR, Abrams EA, Mwansa JK, Denison JA. 'So hurt and broken': A qualitative study of experiences of violence and HIV outcomes among Zambian youth living with HIV. Glob Public Health. 2022 Mar;17(3):444-456. doi: 10.1080/17441692.2020.1864749. Epub 2021 Jan 11.

  PMID: 33428559 DERIVED

• Denison JA, Burke VM, Miti S, Nonyane BAS, Frimpong C, Merrill KG, Abrams EA, Mwansa JK. Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia. PLoS One. 2020 Apr 2;15(4):e0230703. doi: 10.1371/journal.pone.0230703. eCollection 2020.

  PMID: 32240186 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Julie A Denison, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The laboratory staff testing the HIV blood for viral load levels were masked to the participants randomized allocation to the intervention or comparison arms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After about 6 months and the completion of the initial intervention the intervention arm went into a less intensive maintenance phase and the comparison arm started to receive the intervention.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: December 15, 2017
• Primary Completion: February 19, 2019
• Study Completion: June 20, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available six months after the study publications are published.
• Access Criteria: Data will be available under Project SOAR's subsection of the Harvard Dataverse repository. Repository link: https://dataverse.harvard.edu/dataverse/projectsoar

Locations

ZA (1)