HIVNCT03995953
Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
A study testing SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) and Integrated wellness care (IWC) clinics in people with HIV, run by RTI International at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 24 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) and Integrated wellness care (IWC) clinics
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,150 participants
- Where
- 1 siteZambia
- Study dates
- 10 May 2021to 11 Mar 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization), Integrated wellness care (IWC) clinics
- Keywords
- HIV prevention, HIV treatment, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)Behavioural
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.
Integrated wellness care (IWC) clinicsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization); Other: Integrated wellness care (IWC) clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing
Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 12 months since study initiation
Secondary outcomes (16)
HIV Risk Behavior - Delay in First Intercourse
Self-reported age of first intercourse among HIV-/u cohort.
Measured: Baseline
HIV Risk Behavior - Delay in First Intercourse
Self reported age of first intercourse among HIV-/u cohort.
Measured: 6 months
HIV Risk Behavior - Delay in First Intercourse
HIV-/u self reported age of first intercourse.
Measured: 12 months
HIV Risk Behavior - Reduction in Sexual Partners
Self reported number of casual partners in the last 3 months among HIV-/u cohort.
Measured: Baseline
HIV Risk Behavior - Reduction in Sexual Partners
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Measured: 6 months
HIV Risk Behavior - Reduction in Sexual Partners
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Measured: 12 months
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Measured: Baseline
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Measured: 6 months
HIV Risk Behavior - Increases in Condom Use
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Measured: 12 months
HIV Early Detection
HIV-/u proportion with HIV identified through voluntary testing.
Measured: 12 months
Linkages to HIV Care - Enrollment at HIV Clinic
Proportion enrolled at an HIV clinic in ≤ 30 days
Measured: 6 months
Linkages to HIV Care - Enrollment at HIV Clinic
Proportion enrolled at an HIV clinic in ≤ 30 days
Measured: 12 months
Linkages to HIV Care - ART Initiation
Proportion with ART initiated in ≤ 90 days
Measured: 6 months
Linkages to HIV Care - ART Initiation
Proportion with ART initiated in ≤ 90 days
Measured: 12 months
Adherence to ART
AGYW living with HIV who self-reported "Excellent" medication adherence.
Measured: 6 months
Adherence to ART
AGYW living with HIV who self-reported "Excellent" medication adherence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start10 May 2021
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Population Council, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Sujha Subramanian, PhD, Principal investigator, Implenomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995953
- Sponsor's protocol ID
- 1UG3HD096908-01
- Other IDs
- 1UG3HD096908-01
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2019
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41029779Blackburn 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.
PubMed 40111579Subramanian 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.
PubMed 31584004