Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2026-01-10 @ 11:17 AM
Study NCT ID:
NCT06503666
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
Sponsor:
Centre for Infectious Disease Research in Zambia
Organization:
Study Overview
Official Title:
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed hybrid effectiveness-implementation study will systematically adapt the Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (IMARA) curriculum that was previously adapted for South Africa (IMARA-SA) to use in Zambia (will be renamed Zambian Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (ZAIMARA) and evaluate the impact of ZAIMARA on improving adolescent girls and young women HIV testing, HIV and STI incidence, PrEP uptake and sexual risk behaviour. The study will also assess the impact of monthly mental health screening with referral versus a monthly nutrition and exercise screening on peer leaders job retention. We will also examine implementation factors and outcomes associated with ZAIMARA across five sites.
Detailed Description:
The overall purpose of this study is to adapt the IMARA-SA curriculum for use in the Zambian context and test its impact on AGYW sexual behavior, as well as HIV and STI testing uptake and incidence, and PrEP uptake and persistence.
The study will be conducted in two phases. In Phase 1, we will systematically adapt IMARA-SA and the Health Promotion curriculum for use in the Zambian context using a combination of focus groups, CAB meetings, theater testing, and a formal pilot test. The IMARA curriculum focuses on strengthening communication between adolescent girls and young women (AGYW) and their mother figures (MF) to make healthy sexual decisions, to learn more about HIV, sexually transmitted infections (STIs), and pre-exposure prophylaxis (PrEP) while the health promotion (HP) curriculum promotes healthy living by encouraging good nutrition, knowledge on violence exercise, informed consumer behavior and substance use. The HP curriculum does not explicitly address HIV/STI prevention. Once adapted, the IMARA-SA will be renamed Zambian Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (ZAIMARA).
In Phase 2 we will evaluate ZAIMARA's effectiveness on AGYW HIV testing, HIV and STI incidence, PrEP uptake, and sexual behavior. We will recruit 600 AGYW and MF dyads from the community with assistance from neighborhood health committee members (NHC). If participants agree to enroll in the study, consent/ assent will be obtained from AGYW and MF and they will be invited to participate in a 2-day workshop. On the first day of the workshop, the research assistants and study nurse will conduct clinical tests (HIV \& STI), offer PrEP, collect baseline survey data, and randomize AGYW-MF to receive ZAIMARA or health promotion (HP). The peer leaders will administer the ZAIMARA and HP curriculum in the two days. Once the workshops are completed AGYW and MF dyads will graduate from the program and the study team will conduct follow-up assessments at 6, 12, 18, and 24 months. At the follow-up assessments, AGYW-MF will complete a survey, conduct clinical tests (HIV \& STI), and receive PrEP (for eligible participants).
In addition to the trial component, will enroll the peer leaders who provide the intervention (ZAIMARA/HP) in the study. We aim to examine the impact of monthly mental health screening with referral versus a monthly nutrition and exercise screening on peer leader job retention. We will also evaluate ZAIMARA's feasibility, acceptability, appropriateness, fidelity, cost, and sustainability.
The study will occur in five geographically distinct catchment areas in Lusaka that feed into MoH district clinics/hospitals. The five Clinical Research Performance Sites (CRPS) are Kalingalinga Clinic, Chainda South Clinic, Chongwe Urban Clinic, Chelstone Clinic, and Matero first level hospital (subject to change if required). These clinics were selected based on the high volume of adolescents seeking services at these sites and the surrounding community population of AGYW that will allow us to enroll at least 2-3 AGYW-MF dyads per day in the respective sites.
The study will be conducted in two phases. In Phase 1, we will systematically adapt IMARA-SA and the Health Promotion curriculum for use in the Zambian context using a combination of focus groups, CAB meetings, theater testing, and a formal pilot test. The IMARA curriculum focuses on strengthening communication between adolescent girls and young women (AGYW) and their mother figures (MF) to make healthy sexual decisions, to learn more about HIV, sexually transmitted infections (STIs), and pre-exposure prophylaxis (PrEP) while the health promotion (HP) curriculum promotes healthy living by encouraging good nutrition, knowledge on violence exercise, informed consumer behavior and substance use. The HP curriculum does not explicitly address HIV/STI prevention. Once adapted, the IMARA-SA will be renamed Zambian Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (ZAIMARA).
In Phase 2 we will evaluate ZAIMARA's effectiveness on AGYW HIV testing, HIV and STI incidence, PrEP uptake, and sexual behavior. We will recruit 600 AGYW and MF dyads from the community with assistance from neighborhood health committee members (NHC). If participants agree to enroll in the study, consent/ assent will be obtained from AGYW and MF and they will be invited to participate in a 2-day workshop. On the first day of the workshop, the research assistants and study nurse will conduct clinical tests (HIV \& STI), offer PrEP, collect baseline survey data, and randomize AGYW-MF to receive ZAIMARA or health promotion (HP). The peer leaders will administer the ZAIMARA and HP curriculum in the two days. Once the workshops are completed AGYW and MF dyads will graduate from the program and the study team will conduct follow-up assessments at 6, 12, 18, and 24 months. At the follow-up assessments, AGYW-MF will complete a survey, conduct clinical tests (HIV \& STI), and receive PrEP (for eligible participants).
In addition to the trial component, will enroll the peer leaders who provide the intervention (ZAIMARA/HP) in the study. We aim to examine the impact of monthly mental health screening with referral versus a monthly nutrition and exercise screening on peer leader job retention. We will also evaluate ZAIMARA's feasibility, acceptability, appropriateness, fidelity, cost, and sustainability.
The study will occur in five geographically distinct catchment areas in Lusaka that feed into MoH district clinics/hospitals. The five Clinical Research Performance Sites (CRPS) are Kalingalinga Clinic, Chainda South Clinic, Chongwe Urban Clinic, Chelstone Clinic, and Matero first level hospital (subject to change if required). These clinics were selected based on the high volume of adolescents seeking services at these sites and the surrounding community population of AGYW that will allow us to enroll at least 2-3 AGYW-MF dyads per day in the respective sites.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: