Population Council
Lusaka, Zambia
NCT Number: NCT03995953
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.
Looking for future studies?
Notify Me10 year–24 year
Female
Interventional
Not applicable
Lusaka, Zambia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
HIV negative or unknown cohort
HIV positive cohort
Exclusion criteria
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.
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.
Time frame: 6 months
Proportion of cohort not living with HIV that self-reported being 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.
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.
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
Time frame: Baseline
Self-reported age of first intercourse among HIV-/u cohort.
Time frame: 6 months
Self reported age of first intercourse among HIV-/u cohort.
Time frame: 12 months
HIV-/u self reported age of first intercourse.
Time frame: Baseline
Self reported number of casual partners in the last 3 months among HIV-/u cohort.
Time frame: 6 months
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Time frame: 12 months
Self-reported number of casual partners in last 3 months among HIV-/u cohort.
Time frame: Baseline
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: 6 months
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: 12 months
HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
Time frame: 12 months
HIV-/u proportion with HIV identified through voluntary testing.
Time frame: 6 months
Proportion enrolled at an HIV clinic in ≤ 30 days
Time frame: 12 months
Proportion enrolled at an HIV clinic in ≤ 30 days
Time frame: 6 months
Proportion with ART initiated in ≤ 90 days
Time frame: 12 months
Proportion with ART initiated in ≤ 90 days
Time frame: 6 months
AGYW living with HIV who self-reported "Excellent" medication adherence.
Time frame: 12 months
AGYW living with HIV who self-reported "Excellent" medication adherence.
RTI International
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06125509
HIV
Tallahassee, Florida, United States
View Trial DetailsNCT07225894
Behavior, HIV
Kisumu, Kisumu County, Kenya
View Trial DetailsNCT02447159
Behavior, Blood-Borne Infections
Eket, Akwa Ibom State, Nigeria
View Trial DetailsNCT03734393
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Birmingham, Alabama, United States
View Trial Details