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

Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in Zambia

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Integrated wellness care (IWC) clinics; Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)

Detailed Description

The SHIELD intervention aims to improve HIV prevention and care for adolescent girls and young women (AGYW) in Zambia. It is based on social cognitive theory and includes a program for AGYW to increase knowledge, skills, and self-efficacy, as well as a program for family members to increase social support. The intervention also incorporates youth clubs facilitated by peer navigators and integrated wellness clinics (IWC) for sexual and reproductive health services. It will be tailored for five distinct groups based on age and HIV status, with modules covering HIV prevention and treatment, wellness, sexual health, stigma reduction, and healthcare access.

IWC clinics will be established in existing government health facilities, following a model similar to cervical cancer screening clinics. Standard operating procedures (SOPs) will be developed for HIV, HPV vaccination, and sexual and reproductive health services.

Time and motion methodology will monitor AGYW clinic visits to identify areas for improvement. To establish a sampling frame, the study team will identify six clinics in Lusaka, map neighborhoods within the selected clinic catchment areas, and recruit AGYW through household visits by peer navigators.

The HIV-/u cohort will include females aged 10-20 years with self-reported HIV-negative or unknown status. They must not be pregnant or planning pregnancy, be willing to sign a medical records release, plan to reside in the area for 18 months, and not be part of other formative research activities. The study will recruit 1,000 HIV-/u AGYW, with equal numbers in age ranges 10-12, 13-15, and 16-20.

The HIV+ cohort will consist of females aged 16-24 years, diagnosed with HIV within the past 3 years, and meeting the same additional criteria as the HIV-/u cohort. The study will enroll 800 HIV+ AGYW, with equal representation among 16-20 and 21-24 age groups.

AGYW will be encouraged to select caregivers who will participate in some of the education sessions. The role of the caregiver is to support AGYW. Primary and secondary outcomes will be reported for AGYW only.

Data collection will use electronic tablets with pre-loaded software and instruments in multiple languages. Voice-enabled components and self-administration options will be available for sensitive questions. Instruments will be pretested with AGYW and caregivers. The study team will abstract data from clinic records with support from the Zambian Ministry of Health, conducting pilot data abstraction and staff training to ensure high-quality data for the study.

Key aspects of the intervention include tailored education modules for AGYW and caregivers, youth clubs led by peer navigators, and integrated wellness clinics offering comprehensive sexual and reproductive health services.

The SHIELD study aims to improve HIV prevention and care for AGYW in Zambia by addressing knowledge, skills, self-efficacy, social support, and healthcare access through a comprehensive, theory-based intervention. By combining education, social support, and improved healthcare services, the researchers hope to make significant strides in reducing HIV transmission and improving health outcomes for adolescent girls and young women in Zambia.

• Study Type: Interventional
• Enrollment (Actual): 2150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Population Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

HIV negative or unknown cohort

• Female
• 10 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
• 16 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
• has not been part of the other planned formative research activities

Exclusion Criteria:

• pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 2 control clinics, and their associated catchment areas, with no intervention at the clinic or community level
Experimental: SHIELD: Community-based behavioral intervention; 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); 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.
Experimental: SHIELD: Community- based behavioral intervention & IWC Clinic; 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.	Other: Integrated wellness care (IWC) clinics; 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.; Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Risk Behavior - Delay in First Intercourse	Self-reported age of first intercourse among HIV-/u cohort.	Baseline
HIV Risk Behavior - Delay in First Intercourse	Self reported age of first intercourse among HIV-/u cohort.	6 months
HIV Risk Behavior - Delay in First Intercourse	HIV-/u self reported age of first intercourse.	12 months
HIV Risk Behavior - Reduction in Sexual Partners	Self reported number of casual partners in the last 3 months among HIV-/u cohort.	Baseline
HIV Risk Behavior - Reduction in Sexual Partners	Self-reported number of casual partners in last 3 months among HIV-/u cohort.	6 months
HIV Risk Behavior - Reduction in Sexual Partners	Self-reported number of casual partners in last 3 months among HIV-/u cohort.	12 months
HIV Risk Behavior - Increases in Condom Use	HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.	Baseline
HIV Risk Behavior - Increases in Condom Use	HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.	6 months
HIV Risk Behavior - Increases in Condom Use	HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.	12 months
HIV Early Detection	HIV-/u proportion with HIV identified through voluntary testing.	12 months
Linkages to HIV Care - Enrollment at HIV Clinic	Proportion enrolled at an HIV clinic in ≤ 30 days	6 months
Linkages to HIV Care - Enrollment at HIV Clinic	Proportion enrolled at an HIV clinic in ≤ 30 days	12 months
Linkages to HIV Care - ART Initiation	Proportion with ART initiated in ≤ 90 days	6 months
Linkages to HIV Care - ART Initiation	Proportion with ART initiated in ≤ 90 days	12 months
Adherence to ART	AGYW living with HIV who self-reported "Excellent" medication adherence.	6 months
Adherence to ART	AGYW living with HIV who self-reported "Excellent" medication adherence.	12 months

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of North Carolina, Chapel Hill; Population Council
• Investigators: Principal Investigator: Sujha Subramanian, PhD, Implenomics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 11, 2024
• Study Completion (Actual): March 11, 2024

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; Zambia; HIV treatment
• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Health Facilities; Palliative Care; Ambulatory Care Facilities
• Other Study ID Numbers: 1UG3HD096908-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the study, the data will be placed in an NIH electronic database that could be used by researchers outside our study team who are interested in using it to answer questions about access to youth-friendly health services in Zambia. Responses will be inputted after they have been stripped of identifiers such as name, so that it may be used and shared for future research. This research will provide useful feedback for behavior of adolescents at risk or living with HIV in the United States.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No