HIV InfectionsNCT06503666
Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
A study testing ZAIMARA and Health Promotion in people with HIV Infections and Sexually Transmitted Diseases, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- ZAIMARA and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteZambia
- Study dates
- 7 Apr 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Chainda, Matero, Chelston, Chongwe and Kalingalinga
Lusaka, Lusaka Province, 10101
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- ZAIMARA, Health Promotion
- Keywords
- Implementation Science, Adolescent Girls and Young Adults, Low and Middle-Income Country
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZAIMARABehavioural
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 PromotionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Zambian Informed Motivated Aware Responsible Adolescent Girls and Young Adults(ZAIMARA) | Experimental | Intervention Arm Receives: Behavioral: ZAIMARA |
| Health Promotion (HP) | Experimental | Control Arm Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AGYW HIV testing uptake
Proportion of AGYW testing for HIV at 6 months
Measured: Within 6 months following delivery of ZAIMARA & HP curriculum
Secondary outcomes (2)
Incident HIV infection and STIs, PrEP uptake, and AGYW sexual risk behavior
Proportion of AGYW testing positive for HIV \& STIs , Proportion requesting for PrEP and Proportion of AGYW engaging in sexual risk behaviour
Measured: Within 6, 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum
AGYW HIV testing at 12, 18, and 24-months
Proportion of AGYW testing for HIV
Measured: Within 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start7 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AGYW-MF will be randomized to either ZAIMARA or Health Promotion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503666
- Sponsor's protocol ID
- ZAIMARA
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All necessary steps will be taken to ensure adherence to all NIH guidelines on sharing raw data.
Publications
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.
PubMed 12000232Donenberg 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.
PubMed 11392341Donenberg 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.
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.
PubMed 29300099Donenberg 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.
PubMed 33137103Donenberg 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.
PubMed 41029332
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults
- ClinicalTrials.gov ID
- NCT06503666
- Acronym / sponsor ID
- ZAIMARA
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Implementation Science, Adolescent Girls and Young Adults, Low and Middle-Income Country
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of Alabama at Birmingham
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- AGYW-MF will be randomized to either ZAIMARA or Health Promotion.
| Arm | Type | Receives |
|---|---|---|
| Zambian Informed Motivated Aware Responsible Adolescent Girls and Young Adults(ZAIMARA) | Experimental | Behavioral: ZAIMARAIntervention Arm |
| Health Promotion (HP) | Experimental | Behavioral: Health PromotionControl Arm |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZAIMARAThe 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 | Behavioural | Zambian Informed Motivated Aware Responsible Adolescent Girls and Young Adults(ZAIMARA) |
| Health PromotionThe 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 | Behavioural | Health Promotion (HP) |
Primary outcome
AGYW HIV testing uptake
Time frame: Within 6 months following delivery of ZAIMARA & HP curriculum
Proportion of AGYW testing for HIV at 6 months
2 secondary outcomes
Incident HIV infection and STIs, PrEP uptake, and AGYW sexual risk behavior
Time frame: Within 6, 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum
AGYW HIV testing at 12, 18, and 24-months
Time frame: Within 12, 18 and 24 months following delivery of ZAIMARA & HP curriculum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 12000232Donenberg 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.
- Background: PubMed 11392341Donenberg 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.
- BackgroundDonenberg 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: PubMed 29300099Donenberg 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.
- Background: PubMed 33137103Donenberg 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.
- Derived from this study: PubMed 41029332Donenberg 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.
- Individual participant dataSharing planned: Yes. All necessary steps will be taken to ensure adherence to all NIH guidelines on sharing raw data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZAIMARA and Health Promotion in people with HIV Infections and Sexually Transmitted Diseases, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AGYW HIV testing uptake (time frame: Within 6 months following delivery of ZAIMARA & HP curriculum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503666, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.