Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
NCT ID: NCT03995953
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2150 participants
INTERVENTIONAL
2021-05-10
2024-03-11
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
2 control clinics, and their associated catchment areas, with no intervention at the clinic or community level
No interventions assigned to this group
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
10 Years
24 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Population Council
OTHER
University of North Carolina, Chapel Hill
OTHER
RTI International
OTHER
Responsible Party
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Principal Investigators
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Sujha Subramanian, PhD
Role: PRINCIPAL_INVESTIGATOR
Implenomics
Locations
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Population Council
Lusaka, , Zambia
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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