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NCT06503666Active, not recruiting

Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults

Source: ClinicalTrials.gov · Last updated 22 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1200 (estimated)
First submitted
10 Jul 2024
Start date
7 Apr 2025
Primary completion date
1 Dec 2026
Lead sponsor
Centre for Infectious Disease Research in Zambia
Diseases
HIV
NCT number
NCT06503666

What you commit to

  • Study type: Interventional
  • Planned participants: 1200
  • From 7 Apr 2025 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • AGYW

Who the study is looking for

  • Adolescent girls and young women (AGYW)
  • 15-19 years-old females (sex assigned at birth)
  • Unmarried
  • Residing outside the five study catchment areas
  • Speak Nyanja, Bemba, or English or a combination (the primary regional languages)
  • Willing and able to provide consent (\> 18 years old) and/or assent (\< 18 years old)
  • Not known to be living with HIV (i.e., no positive test and not on ART)
    • Mother Figures (MF)
  • selected to participate by the AGYW
  • if not the guardian/mother, agreed upon by the guardian/mother
  • \> 24 years-old
  • living with or in daily contact with the AGYW
  • speak Nyanja, Bemba, or English or a combination
  • Willing and able to provide consent
    • Peer leaders (ZAIMARA \& Health Promotion)
  • live in the community where they will be working
  • have prior experience working with young people
  • have a minimum grade 12 education
  • be proficient in reading and writing English and/or Nyanja or Bemba
  • are 22-29 years old for AGYW sessions
  • are \>30 years-old for MF sessions

Age in the registry: 15 years to 70 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chainda, Matero, Chelston, Chongwe and Kalingalinga
Coordinator of this site? Confirm its status
LusakaZambiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.