Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503666
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 HIVSTI 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 ZAIMARAs 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 ZAIMARAHP 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 ZAIMARAs feasibility acceptability appropriateness fidelity cost and sustainability
The study will occur in five geographically distinct catchment areas in Lusaka that feed into MoH district clinicshospitals 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 HIVSTI 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 ZAIMARAs 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 ZAIMARAHP 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 ZAIMARAs feasibility acceptability appropriateness fidelity cost and sustainability
The study will occur in five geographically distinct catchment areas in Lusaka that feed into MoH district clinicshospitals 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None