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Completed

NCT Number: NCT03995953

Integrated Care Delivery of HIV Prevention and Treatment in AGYW 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.

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Key information

Conditions

HIV

Age range

10 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Population Council

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. HIV Testing

    Time frame: 6 months

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

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

    Time frame: 12 months

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

  3. Retention in Care

    Time frame: 12 months

    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.

  4. HIV+ Proportion With Undetectable Viral Load at 12 Months

    Time frame: At 12 months since study initiation

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

Secondary outcomes

  1. HIV Risk Behavior - Delay in First Intercourse

    Time frame: Baseline

    Self-reported age of first intercourse among HIV-/u cohort.

  2. HIV Risk Behavior - Delay in First Intercourse

    Time frame: 6 months

    Self reported age of first intercourse among HIV-/u cohort.

  3. HIV Risk Behavior - Delay in First Intercourse

    Time frame: 12 months

    HIV-/u self reported age of first intercourse.

  4. HIV Risk Behavior - Reduction in Sexual Partners

    Time frame: Baseline

    Self reported number of casual partners in the last 3 months among HIV-/u cohort.

  5. HIV Risk Behavior - Reduction in Sexual Partners

    Time frame: 6 months

    Self-reported number of casual partners in last 3 months among HIV-/u cohort.

  6. HIV Risk Behavior - Reduction in Sexual Partners

    Time frame: 12 months

    Self-reported number of casual partners in last 3 months among HIV-/u cohort.

  7. HIV Risk Behavior - Increases in Condom Use

    Time frame: Baseline

    HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

  8. HIV Risk Behavior - Increases in Condom Use

    Time frame: 6 months

    HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

  9. HIV Risk Behavior - Increases in Condom Use

    Time frame: 12 months

    HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.

  10. HIV Early Detection

    Time frame: 12 months

    HIV-/u proportion with HIV identified through voluntary testing.

  11. Linkages to HIV Care - Enrollment at HIV Clinic

    Time frame: 6 months

    Proportion enrolled at an HIV clinic in ≤ 30 days

  12. Linkages to HIV Care - Enrollment at HIV Clinic

    Time frame: 12 months

    Proportion enrolled at an HIV clinic in ≤ 30 days

  13. Linkages to HIV Care - ART Initiation

    Time frame: 6 months

    Proportion with ART initiated in ≤ 90 days

  14. Linkages to HIV Care - ART Initiation

    Time frame: 12 months

    Proportion with ART initiated in ≤ 90 days

  15. Adherence to ART

    Time frame: 6 months

    AGYW living with HIV who self-reported "Excellent" medication adherence.

  16. Adherence to ART

    Time frame: 12 months

    AGYW living with HIV who self-reported "Excellent" medication adherence.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2019
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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