Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults

NCT06503666 | Recruiting DMC

• 1 other identifier: ZAIMARA
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Diseases

Keywords

Implementation Science; Adolescent Girls and Young Adults; Low and Middle-Income Country

Outcome Measures

Primary Outcomes (1)

• AGYW HIV testing uptake

  Proportion of AGYW testing for HIV at 6 months

  Within 6 months following delivery of ZAIMARA & HP curriculum

Secondary Outcomes (2)

• Incident HIV infection and STIs, PrEP uptake, and AGYW sexual risk behavior

  Within 6, 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum

• AGYW HIV testing at 12, 18, and 24-months

  Within 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum

Study Arms (2)

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

EXPERIMENTAL

Intervention Arm

Behavioral: ZAIMARA

Health Promotion (HP)

EXPERIMENTAL

Control Arm

Behavioral: Health Promotion

Interventions

ZAIMARA 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

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

Health Promotion 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

Health Promotion (HP)

Eligibility Criteria

• Age: 15 Years - 70 Years
• Gender Eligibility Details: All female participants (Sex assigned at birth for AGYW and MF)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescent girls and young women (AGYW)
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• University of Illinois at Chicago: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Chainda, Matero, Chelston, Chongwe and Kalingalinga

Lusaka, Lusaka Province, 10101, Zambia

RECRUITING

Related Publications (6)

• Donenberg GR, Wilson HW, Emerson E, Bryant FB. Holding the line with a watchful eye: the impact of perceived parental permissiveness and parental monitoring on risky sexual behavior among adolescents in psychiatric care. AIDS Educ Prev. 2002 Apr;14(2):138-57. doi: 10.1521/aeap.14.2.138.23899.

  PMID: 12000232 BACKGROUND

• Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642-53. doi: 10.1097/00004583-200106000-00008.

  PMID: 11392341 BACKGROUND

• Donenberg G. Donenberg GR, Brown LK, Hadley W, Kapungu C, Lescano C. Family-based HIV-prevention program for adolescents with psychiatric disorders. In: Pequegnat W, Bell C, editors. Families and HIV/AIDS: Culture and contextual issues in prevention and treatment. New York: Springer; 2012.

  BACKGROUND

• Donenberg G, Emerson E, Mackesy-Amiti ME, Fletcher F. Sexual risk among African American girls seeking psychiatric care: A social-personal framework. J Consult Clin Psychol. 2018 Jan;86(1):24-38. doi: 10.1037/ccp0000270.

  PMID: 29300099 BACKGROUND

• Donenberg GR, Kendall AD, Emerson E, Fletcher FE, Bray BC, McCabe K. IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents. PLoS One. 2020 Nov 2;15(11):e0239650. doi: 10.1371/journal.pone.0239650. eCollection 2020.

  PMID: 33137103 BACKGROUND

• Donenberg GR, Sharma A, Kanguya T, Emerson E, Chhun N, Kasengele CT, Mweemba M, Mwenge M, Bosomprah S, Sissoko GD, Hosek S, Moore CB. A hybrid effectiveness implementation trial testing an HIV and STI prevention program for mother figures and their adolescent girls and young women delivered by peer leaders: ZAIMARA study protocol. BMC Public Health. 2025 Sep 30;25(1):3153. doi: 10.1186/s12889-025-24332-5.

  PMID: 41029332 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Carolyn Bolton

CONTACT

+260211242 257; carolyn.bolton@cidrz.org

Geri Donenberg

CONTACT

312-996-8602; gerid@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Pending
• Access Criteria: Pending

Locations

ZA (1)