Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2028-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IMARA, Adapting SiHLE for Detained African American Adolescent Females

NCT00746369

HIV Infections

COMPLETED NA

A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA

NCT05504954

Sexually Transmitted Infection Hiv

COMPLETED NA

A Community-based Implementation Model for HIV Prevention and Testing in Malawi

NCT02765659

HIV CDC Category A1

COMPLETED NA

A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

NCT04758390

Sexually Transmitted Infections HIV Infections

COMPLETED NA

Promoting Uptake and Retention of Option B+ in Malawi

NCT02005835

HIV

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Sexually Transmitted Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

AGYW-MF will be randomized to either ZAIMARA or Health Promotion.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the study, masking of AGYW-MF participants is not possible. Our research assistants will be masked to the randomization scheme.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zambian Informed Motivated Aware Responsible Adolescent Girls and Young Adults(ZAIMARA)

Intervention Arm

Group Type EXPERIMENTAL

ZAIMARA

Intervention Type BEHAVIORAL

The ZAIMARA 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). The topics in the curriculum focus on effective communication, mothers talking to daughters on sex, HIV, STIs and PrEP. The intervention consists of participants attending a two day workshops with their MF.

Other names:

ZAIMARA

Health Promotion (HP)

Control Arm

Group Type EXPERIMENTAL

Health Promotion

Intervention Type BEHAVIORAL

The health promotion (HP) curriculum focuses on healthy living by encouraging good nutrition, improving knowledge on violence recognition, management and support/resources, exercise, informed consumer behavior, alcohol and substance use.The intervention consists of participants attending a two day workshops with their MF.

Other names:

HP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ZAIMARA

The ZAIMARA 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). The topics in the curriculum focus on effective communication, mothers talking to daughters on sex, HIV, STIs and PrEP. The intervention consists of participants attending a two day workshops with their MF.

Other names:

ZAIMARA

Intervention Type BEHAVIORAL

Health Promotion

The health promotion (HP) curriculum focuses on healthy living by encouraging good nutrition, improving knowledge on violence recognition, management and support/resources, exercise, informed consumer behavior, alcohol and substance use.The intervention consists of participants attending a two day workshops with their MF.

Other names:

HP

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Adolescent girls and young women (AGYW)

1. 15-19 years-old females (sex assigned at birth)
2. Unmarried
3. Residing outside the five study catchment areas
4. Speak Nyanja, Bemba, or English or a combination (the primary regional languages)
5. Willing and able to provide consent (\> 18 years old) and/or assent (\< 18 years old)
6. Not known to be living with HIV (i.e., no positive test and not on ART)

Mother Figures (MF)

1. selected to participate by the AGYW
2. if not the guardian/mother, agreed upon by the guardian/mother
3. \> 24 years-old
4. living with or in daily contact with the AGYW
5. speak Nyanja, Bemba, or English or a combination
6. Willing and able to provide consent

Peer leaders (ZAIMARA \& Health Promotion)

1. live in the community where they will be working
2. have prior experience working with young people
3. have a minimum grade 12 education
4. be proficient in reading and writing English and/or Nyanja or Bemba
5. are 22-29 years old for AGYW sessions
6. are \>30 years-old for MF sessions

Exclusion Criteria

AGYW

AGYW who are enrolled in other SRH interventions at the time of recruitment (to prevent confounding) or are known to be living with HIV (the needs of AGYW living with HIV are unique and not well-addressed in IMARA-SA, e.g., learning to disclose) will be excluded. Importantly, AGYW who test positive for HIV at the study's baseline assessment will be able to complete the workshops and referred for treatment to avoid stigma.

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes