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Project YES! Youth Engaging for Success (Project YES!)

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ClinicalTrials.gov Identifier: NCT04115813
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Population Council
Arthur Davison Childrens Hospital
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Project YES! Youth Engaging for Success Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The laboratory staff testing the HIV blood for viral load levels were masked to the participants randomized allocation to the intervention or comparison arms.
Primary Purpose: Supportive Care
Official Title: Transitioning Adolescents to HIV Self-Management in Zambia (Known as: Project YES: Youth Engaging for Success)
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention Arm
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
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
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
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.




Primary Outcome Measures :
  1. Proportion of Participants with Viral Suppression (<1000 copies/mL) at Baseline and Midline [ Time Frame: ~ 6 months (from baseline to midline) ]
    <1000 copies/mL


Secondary Outcome Measures :
  1. Proportion of Participants with Internalized Stigma (binary, yes to two out of three questions) at baseline and midline. [ Time Frame: ~ 6 months (from baseline to midline) ]
    Internalized stigma was measured at both time points using three agree/disagree questions from the Internalized AIDS Stigma Scale (IA-RSS) (Kalichman et al. AIDSCare 2009). This measure asks participants to either "agree" or "disagree" with each of the following three statements: (1) You feel guilty that you are HIV positive; (2) You are ashamed that you are HIV positive; and (3) You sometimes feel worthless because you are HIV positive to measure self-stigma (also known as internalized stigma). Responses range from 0-3 with 3 indicating higher/worse experiences of internalized stigma. From this data, a binary outcome was generated with "1" indicating that the participant answered "agree" to at least two of the three questions, and "0" otherwise.

  2. Proportion of Participants with Antiretroviral Adherence Treatment Gap at baseline and midline [ Time Frame: ~ 6 months (from baseline to midline) ]
    >= 48 consecutive hours or more of missed ART (self-reported)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115813


Locations
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Zambia
Arthur Davison Children's Hospital
Ndola, Copperbelt Province, Zambia
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
Population Council
Arthur Davison Childrens Hospital
Investigators
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Principal Investigator: Julie A Denison, PhD Johns Hopkins Bloomberg School of Public Health

Additional Information:
Publications:

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04115813    
Other Study ID Numbers: IRB00007870
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study team plans to share the study data collection tools and de-identified data six months after the study manuscripts are published.
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
URL: https://dataverse.harvard.edu/dataverse/projectsoar

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Adolescents
Young Adults
Antiretroviral Therapy
Caregivers
Support Groups