Sexually Transmitted InfectionIMARA-SA pilotNCT05504954
A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA
A study testing IMARA-SA (intervention group) in people with Sexually Transmitted Infection and Hiv, run by University of Illinois Chicago at 1 site in South Africa.
Trial summary
Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection, Hiv
- What is being tested?
- IMARA-SA (intervention group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Oct 2019to 15 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Black or mixed race;
- 15-19 years-old;
- residing in Klipfontein/Mitchells Plain (K/MP);
- speak isiXhosa or English or a combination of these languages.
- identified by AGYW as a FC;
- 24 years and older;
- living with or in daily contact with the AGYW;
- speak isiXhosa or English or a combination of these languages.
Who cannot join
- AGYW will be excluded from the study if they do not have a FC to participate in the study.
- AGYW and FC will be excluded from the study if they:
- are unable to understand the consent/assent process and provide written informed consent;
- are currently enrolled in another research study addressing HIV/STIs/PrEP;
- participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. This pilot study will assess feasibility in preparation for a randomized controlled trial (RCT). Additionally, the pilot will examine the preliminary effectiveness of IMARA-SA in reducing sexually transmitted infections (STI) and increasing uptake of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at follow-up among AGYW. About 60 AGYW-FC dyads will be enrolled and randomized to IMARA-SA or a health-promotion control arm. Following randomization, the dyads will participate in an ~2-day group workshop (~10 hours), which includes joint and separate mother and daughter activities. AGYW and FC will complete baseline assessments and follow-up assessments approximately 6 months later. Assessments will include surveys, STIs testing (for chlamydia and gonorrhea), and uptake of HTC and a 1-month PrEP prescription. Additionally, the intervention's implementation (e.g., acceptability) will be explored.
- Conditions
- Sexually Transmitted Infection, Hiv
- Being tested
- IMARA-SA (intervention group), Health promotion control group
- Keywords
- HIV prevention, Adolescent girls and young women, South Africa, Mother-daughter intervention
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMARA-SA (intervention group)Behavioural
The IMARA-SA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA-SA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA-SA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.
Health promotion control groupBehavioural
The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.
| Study group | Role | What they receive |
|---|---|---|
| IMARA-SA intervention arm | Experimental | Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group). Receives: Behavioral: IMARA-SA (intervention group) |
| Health promotion control arm | Experimental | Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group). Receives: Behavioral: Health promotion control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)
A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Measured: 8-17 months post baseline
Number of AGYW Completing HIV Testing and Counseling (HTC)
Completion of HIV Testing and Counseling (HTC)
Measured: 8-17 months post baseline
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)
Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.
Measured: 8-17 months post baseline
Secondary outcomes (5)
AGYW's Report of Adherence to PrEP
Adherence to PrEP is measured using an adapted version of the Wilson scale (2017).
Measure Description: (0=low adherence to 100=high adherence) Scale is comprised of 3 items: number of days dose missed, how often did you take PrEP in the way you were supposed to, how good a job did you do at taking PrEP.
Items were transformed to a 0-100 scale and averaged. Thirty was subtracted from number of days missed and multiplied by 3.33. Responses for remaining 2 items: never/very poor=0, rarely/poor=20, sometimes/fair=40, usually/good=60, almost always/very good=80, always/excellent=100.
Measured: 6-10 months post baseline
AGYW Condom Use at Last Sex
Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).
Measured: 6-10 months post baseline
AGYW Consistency of Condom Use
Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Measured: 6-10 months post baseline
AGYW Substance Use During Sex in the Past 6 Months
Self-reported number of times had vaginal or anal sex while drinking or taking drugs in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Measured: 6-10 months post baseline
Number of Partners in the Past 6 Months
Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Measured: 6-10 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start26 Oct 2019
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA-SA intervention arm or a health promotion control arm matched in time and intensity. IMARA-SA and the health promotion program will be delivered as group interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Desmond Tutu HIV Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Natasha Crooks, University of Illinois Chicago
- Investigators
- Geri R Donenberg, PhD, Principal investigator, University of Illinois ChicagoLinda-Gail Bekker, MBChB, PhD, Principal investigator, Desmond Tutu HIV Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504954
- Sponsor's protocol ID
- UG3HD096875
- Acronym
- IMARA-SA pilot
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2022
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request, pending discussion with the study team about the planned use of the data.
Publications
Merrill KG, Atujuna M, Emerson E, Blachman-Demner D, Bray BC, Bekker LG, Donenberg GR. Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial. PLOS Glob Public Health. 2023 Feb 15;3(2):e0001092. doi: 10.1371/journal.pgph.0001092. eCollection 2023.
PubMed 36962830
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
- ClinicalTrials.gov ID
- NCT05504954
- Acronym / sponsor ID
- IMARA-SA pilot / UG3HD096875
- Conditions
- Sexually Transmitted Infection, Hiv
- Keywords
- HIV prevention, Adolescent girls and young women, South Africa, Mother-daughter intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Desmond Tutu HIV Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Oct 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. This pilot study will assess feasibility in preparation for a randomized controlled trial (RCT). Additionally, the pilot will examine the preliminary effectiveness of IMARA-SA in reducing sexually transmitted infections (STI) and increasing uptake of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at follow-up among AGYW. About 60 AGYW-FC dyads will be enrolled and randomized to IMARA-SA or a health-promotion control arm. Following randomization, the dyads will participate in an ~2-day group workshop (~10 hours), which includes joint and separate mother and daughter activities. AGYW and FC will complete baseline assessments and follow-up assessments approximately 6 months later. Assessments will include surveys, STIs testing (for chlamydia and gonorrhea), and uptake of HTC and a 1-month PrEP prescription. Additionally, the intervention's implementation (e.g., acceptability) will be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA-SA intervention arm or a health promotion control arm matched in time and intensity. IMARA-SA and the health promotion program will be delivered as group interventions.
| Arm | Type | Receives |
|---|---|---|
| IMARA-SA intervention arm | Experimental | Behavioral: IMARA-SA (intervention group)Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group). |
| Health promotion control arm | Experimental | Behavioral: Health promotion control groupParticipants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group). |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Black or mixed race;
- 15-19 years-old;
- residing in Klipfontein/Mitchells Plain (K/MP);
- speak isiXhosa or English or a combination of these languages.
- identified by AGYW as a FC;
Key exclusion criteria (5 listed)
- AGYW will be excluded from the study if they do not have a FC to participate in the study.
- are unable to understand the consent/assent process and provide written informed consent;
- are currently enrolled in another research study addressing HIV/STIs/PrEP;
- participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.
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 |
|---|---|---|
| IMARA-SA (intervention group)The IMARA-SA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA-SA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA-SA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk. | Behavioural | IMARA-SA intervention arm |
| Health promotion control groupThe health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity. | Behavioural | Health promotion control arm |
Primary outcome
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)
Time frame: 8-17 months post baseline
A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Number of AGYW Completing HIV Testing and Counseling (HTC)
Time frame: 8-17 months post baseline
Completion of HIV Testing and Counseling (HTC)
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)
Time frame: 8-17 months post baseline
Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.
5 secondary outcomes
AGYW's Report of Adherence to PrEP
Time frame: 6-10 months post baseline
AGYW Condom Use at Last Sex
Time frame: 6-10 months post baseline
AGYW Consistency of Condom Use
Time frame: 6-10 months post baseline
AGYW Substance Use During Sex in the Past 6 Months
Time frame: 6-10 months post baseline
Number of Partners in the Past 6 Months
Time frame: 6-10 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36962830Merrill KG, Atujuna M, Emerson E, Blachman-Demner D, Bray BC, Bekker LG, Donenberg GR. Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial. PLOS Glob Public Health. 2023 Feb 15;3(2):e0001092. doi: 10.1371/journal.pgph.0001092. eCollection 2023.
- Individual participant dataSharing planned: Yes. Data will be available on request, pending discussion with the study team about the planned use of the 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.
Geri R Donenberg, PhD principal investigator
University of Illinois Chicago
Linda-Gail Bekker, MBChB, PhD principal investigator
Desmond Tutu HIV Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMARA-SA (intervention group) in people with Sexually Transmitted Infection and Hiv, run by University of Illinois Chicago at 1 site in South Africa.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2025. 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 South Africa. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI) (time frame: 8-17 months post baseline). The study lists 3 primary outcomes in all. 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 NCT05504954, which also lists 1 linked publication.
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 Aug 2025.