Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia

NCT03995953 | Completed Results DMC

• 1 other identifier: 1UG3HD096908-01
• Study Type: interventional
• Target: 2,150
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented where AGYW participants, stratified by age group and HIV status, will be randomized based on their residence within the six study clinic catchment areas, into the following intervention arms: no intervention, the SHIELD intervention, and the SHIELD intervention and IWC clinics.

Conditions

HIV

Keywords

HIV prevention; HIV treatment; Zambia

Outcome Measures

Primary Outcomes (4)

• HIV Testing

  Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.

  6 months

• HIV-/u Proportion Tested for HIV in the Past 6 Months

  Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months.

  12 months

• Retention in Care

  HIV+ cohort proportion with at least one visit during the 12-months follow-up. Data were not collected from any participant due to COVID 19 pandemic and associated restrictions, and will not be collected in the future.

  12 months

• HIV+ Proportion With Undetectable Viral Load at 12 Months

  Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load

  At 12 months since study initiation

Secondary Outcomes (16)

• HIV Risk Behavior - Delay in First Intercourse

  Baseline

• HIV Risk Behavior - Delay in First Intercourse

  6 months

• HIV Risk Behavior - Delay in First Intercourse

  12 months

• HIV Risk Behavior - Reduction in Sexual Partners

  Baseline

• HIV Risk Behavior - Reduction in Sexual Partners

  6 months

Study Arms (3)

Control

NO INTERVENTION

2 control clinics, and their associated catchment areas, with no intervention at the clinic or community level

SHIELD: Community-based behavioral intervention

EXPERIMENTAL

2 clinics, and their associated catchment areas, where participants attend modules designed to educate and empower adolescent girls and young women (AGYWs) and their caregivers, along with attendance at community-based youth clubs to foster peer support.

Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)

SHIELD: Community- based behavioral intervention & IWC Clinic

EXPERIMENTAL

2 clinics, and their associated catchment areas, where participants and their caregivers receive the Support for HIV Integrated Education, Linkages to care, and Destigmatization (SHIELD) intervention along with the coupled benefits of having an integrated wellness care (IWC) clinic within health facilities where adolescent girls and young women (AGYWs) can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and human papilloma virus (HPV) vaccination.

Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization); Other: Integrated wellness care (IWC) clinics

Interventions

SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) BEHAVIORAL

The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for caregivers to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.

SHIELD: Community- based behavioral intervention & IWC Clinic; SHIELD: Community-based behavioral intervention

Integrated wellness care (IWC) clinics OTHER

IWC clinics will be created within health facilities where AGYWs can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and HPV vaccination in a youth-friendly environment.

SHIELD: Community- based behavioral intervention & IWC Clinic

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV negative or unknown cohort
• Female
• to 20 years of age
• self-report HIV status as negative or unknown (no HIV testing within the past 6 months
• not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
• is willing to sign a release for medical records (to obtain clinic data on service use)
• plans to reside in the current location for the next 18 months
• has not been part of the other planned formative research activities
• HIV positive cohort
• Female
• to 24 years of age
• diagnosed with HIV within the past 3 years or newly diagnosed at the time of the study
• not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
• is willing to sign a release for medical records (to obtain clinic data on service use)
• plans to reside in the current location for the next 18 months

You may not qualify if:

• pregnant

Sponsors & Collaborators

• RTI International: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Population Council: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Population Council

Lusaka, Zambia

Location

Related Publications (3)

• Scanlon SL, Blackburn NA, Beizer J, Mulenga DM, Nyblade L, Roberts ST, Chelwa N, Mbizvo M, Subramanian S. Comparison of sexual risk behaviors among Zambian adolescent girls and young women living with and without HIV. Reprod Health. 2025 Sep 30;22(1):174. doi: 10.1186/s12978-025-02147-2.

  PMID: 41029779 DERIVED

• Blackburn NA, Scanlon SL, Beizer J, Chelwa N, Nyblade L, Roberts ST, Phiri L, Mulenga D, Mbizvo M, Subramanian S. The Implementation and Costs To Deliver a youth-friendly multi-component Program Addressing Stigma, HIV, and Linkage To Care for Adolescent Girls and Young Women in Lusaka, Zambia. AIDS Behav. 2025 Jul;29(7):2179-2188. doi: 10.1007/s10461-025-04682-2. Epub 2025 Mar 20.

  PMID: 40111579 DERIVED

• Subramanian S, Edwards P, Roberts ST, Musheke M, Mbizvo M. Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 3;8(10):e15314. doi: 10.2196/15314.

  PMID: 31584004 DERIVED

MeSH Terms

Interventions

Palliative Care; Ambulatory Care Facilities

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Facilities

Results Point of Contact

• Title: Sujha Subramanian
• Organization: Implenomics

sujha.subramanian@implenomics.com

(302) 200 8310

Study Officials

• Sujha Subramanian, PhD

  Implenomics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Based on their residence in the catchment areas of the six selected study clinics, AGYW participants, stratified by age group and HIV status, will be randomized into the following three treatment arms: no intervention, the SHIELD intervention, and the SHIELD intervention and IWC clinics. The sample size was calculated assuming conventional specifications (power = .80, alpha = .05, two-sided tests) and based on the primary endpoints.

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: May 10, 2021
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)