Sexually Transmitted InfectionsIMARA-SANCT04758390
A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
A study testing IMARA (intervention group) in people with Sexually Transmitted Infections and HIV Infections, run by University of Illinois Chicago at 1 site in South Africa.
Trial summary
To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. 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 Infections, HIV Infections
- What is being tested?
- IMARA (intervention group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,290 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 Oct 2021to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- female;
- 15-19 years-old;
- residing in Klipfontein/Mitchells Plain (K/MP);
- speak isiXhosa or English or a combination of these languages;
- willing to have biometric data collected.
- identified by AGYW as a FC;
Show all 10Show fewer
- 24 years and older;
- living with or in daily contact with the AGYW;
- speak isiXhosa or English or a combination of these languages;
- willing to have biometric data collected.
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: a) unable to understand the consent/assent process and provide written informed consent; b) currently enrolled in another research study addressing HIV/STIs/PrEP.
- 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
To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) 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. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.
Read the detailed description
Reducing new HIV and STI infections among South African (SA) adolescent girls and young women (AGYW) is global public health priority. SA has the world's largest HIV epidemic, and SA AGYW acquire HIV at twice the rate of and seroconvert on average 5 - 7 years earlier than male peers. As new infections continue to outpace access to and availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), primary prevention remains the most viable strategy to stem new transmission. SA efforts to prevent HIV transmission in youth focus mostly on individual-level behavior change, but AGYW's persistent HIV disparities are explained by broad social and structural inequities that shape and constrain HIV-risk behaviors. Comprehensive HIV prevention packages that are integrated, synergistic, and tailored to the local epidemiology and cultural context are likely to achieve and sustain maximum reductions in HIV-risk. Female caregivers (FC) are an untapped resource in the HIV prevention toolbox and offer a novel opportunity to strengthen AGYW prevention efforts. AGYW may also be change agents for their FC who want to be positive role models for AGYW, and thus, adopt HIV prevention behaviors, including HTC and PrEP.
This study will evaluate the effectiveness and cost-effectiveness of Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), a multilevel, innovative, family-based HIV prevention program that targets individual, social, and structural drivers of risk. IMARA demonstrated a 43% reduction in incident STI at 12-month follow-up among black 14-18-year-old girls in the US. IMARA has been systematically tailored for the SA context and piloted among AGYW and FC dyads. A two-arm RCT will now be conducted with about 645 AGYW (15-19 years old) and FC dyads. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (~12 hours) that includes joint and separate mother and daughter activities. AGYW and FC will complete baseline, 6-, and 12-month assessments, including testing for three STI (chlamydia, gonorrhea, and trichomoniasis). We will offer HTC and PrEP at each assessment and track uptake and linkage to care. AGYW and FC who are HIV-negative and interested in PrEP will receive a one-month supply and referral to a clinic. They will additionally receive treatment and counseling if testing positive for an STI and referral for care at an ART clinic if testing positive for HIV. Data will be collected to determine the costs of IMARA. Analyses will compare AGYW across the intervention and control programs on STI incidence, and PrEP and HTC uptake, in addition to secondary outcomes. We will also evaluate the costs and cost-effectiveness of IMARA with respect to the acquisition of STI and HIV, where possible considering power limitations. Additionally, the intervention's implementation will be explored. The study answers an urgent need to evaluate the effectiveness and cost-effectiveness of combination HIV prevention packages for AGYW.
- Conditions
- Sexually Transmitted Infections, HIV Infections
- Being tested
- IMARA (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, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMARA (intervention group)Behavioural
The IMARA 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'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 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 intervention arm | Experimental | Participants randomized to the IMARA arm will receive the IMARA intervention (i.e., the intervention group). Receives: Behavioral: IMARA (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.
Proportion of adolescent girls and young women (AGYW) with a sexually-transmitted infection (STI) at baseline and midline
A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis
Measured: ~6 months (from baseline to midline)
Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and midline
Completion of HTC
Measured: ~6 months (from baseline to midline)
Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and midline
Uptake of PrEP
Measured: ~6 months (from baseline to midline)
Secondary outcomes (8)
Proportion of AGYW with an STI at baseline and endline
A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis
Measured: ~12 months (from baseline to endline)
Proportion of AGYW who complete HTC at baseline and endline
Completion of HTC
Measured: ~12 months (from baseline to endline)
Proportion of AGYW who elect to take PrEP at baseline and endline
Uptake of PrEP
Measured: ~12 months (from baseline to endline)
Proportion of AGYW who report risky sexual behavior at baseline, midline, and endline
Sexual behavior (e.g., condom use, substance use during sex, number of partners, concurrent partners) will be measured via self-report using the AIDS Risk Behavior Assessment (ARBA) (Donenberg, 2001).
Measured: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who report adherence to PrEP at baseline, midline, and endline
Adherence to PrEP (where appropriate) will be measured via self-report using items from the Wilson scale (2017)
Measured: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who report adherence to antiretroviral therapy (ART) at baseline, midline, and endline
Adherence to ART (where appropriate) will be measured via self-report using items from the Wilson scale (2017)
Measured: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who test positive for HIV at baseline, midline, and endline
A positive test for HIV during HTC
Measured: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Intervention cost-effectiveness
The cost-effectiveness ratio, defined as the incremental cost of the IMARA intervention per infection prevented by the intervention.
Measured: The study duration (~2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start2 Oct 2021
- Primary completion7 Apr 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies 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 intervention arm or a health promotion control arm matched in time and intensity. IMARA and the health promotion program will be delivered as group interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Desmond Tutu Health Foundation, 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 Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758390
- Sponsor's protocol ID
- 2018-0709
- Other IDs
- UH3HD096875
- Acronym
- IMARA-SA
- Status last verified
- Jan 2025
- First submitted
- 11 Feb 2021
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be placed in one or more electronic databases (e.g. DASH, PATC3H) which could be used for other research studies in addition to this one.
Publications
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.
PubMed 33137103Atujuna M, Merrill K, Ndwayana S, Emerson E, Fynn L, Bekker L-G, Donenberg G: Engaging female caregivers to improve South African girls' and young womens' sexual and reproductive health outcomes. In: HIV Research for Prevention Virtual Conference. 2021.
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.
PubMed 11392341Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
PubMed 27098408Haroz EE, Bolton P, Nguyen AJ, Lee C, Bogdanov S, Bass J, Singh NS, Doty B, Murray L. Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC Health Serv Res. 2019 Apr 29;19(1):262. doi: 10.1186/s12913-019-4097-y.
PubMed 31036002Lane KL, Bocian KM, MacMillan DL, Gresham FM. Treatment integrity: An essential-but often forgotten-component of school-based interventions. Preventing School Failure. 2004; 48(3): 36-43.
Norton WE. An exploratory study to examine intentions to adopt an evidence-based HIV linkage-to-care intervention among state health department AIDS directors in the United States. Implement Sci. 2012 Apr 2;7:27. doi: 10.1186/1748-5908-7-27.
PubMed 22471965Donenberg G, Merrill KG, Atujuna M, Emerson E, Bray B, Bekker LG. Mental health outcomes of a pilot 2-arm randomized controlled trial of a HIV-prevention program for South African adolescent girls and young women and their female caregivers. BMC Public Health. 2021 Nov 30;21(1):2189. doi: 10.1186/s12889-021-12010-1.
PubMed 34847908Donenberg GR, Atujuna M, Merrill KG, Emerson E, Ndwayana S, Blachman-Demner D, Bekker LG. An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol. BMC Public Health. 2021 Sep 20;21(1):1708. doi: 10.1186/s12889-021-11727-3.
PubMed 34544403
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 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
- NCT04758390
- Acronym / sponsor ID
- IMARA-SA / 2018-0709
- Conditions
- Sexually Transmitted Infections, HIV Infections
- Keywords
- HIV prevention, Adolescent girls and young women, South Africa, Mother-daughter intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Desmond Tutu Health Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 17 Feb 2021 (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.
To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) 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. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.
Detailed description
Reducing new HIV and STI infections among South African (SA) adolescent girls and young women (AGYW) is global public health priority. SA has the world's largest HIV epidemic, and SA AGYW acquire HIV at twice the rate of and seroconvert on average 5 - 7 years earlier than male peers. As new infections continue to outpace access to and availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), primary prevention remains the most viable strategy to stem new transmission. SA efforts to prevent HIV transmission in youth focus mostly on individual-level behavior change, but AGYW's persistent HIV disparities are explained by broad social and structural inequities that shape and constrain HIV-risk behaviors. Comprehensive HIV prevention packages that are integrated, synergistic, and tailored to the local epidemiology and cultural context are likely to achieve and sustain maximum reductions in HIV-risk. Female caregivers (FC) are an untapped resource in the HIV prevention toolbox and offer a novel opportunity to strengthen AGYW prevention efforts. AGYW may also be change agents for their FC who want to be positive role models for AGYW, and thus, adopt HIV prevention behaviors, including HTC and PrEP.
This study will evaluate the effectiveness and cost-effectiveness of Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), a multilevel, innovative, family-based HIV prevention program that targets individual, social, and structural drivers of risk. IMARA demonstrated a 43% reduction in incident STI at 12-month follow-up among black 14-18-year-old girls in the US. IMARA has been systematically tailored for the SA context and piloted among AGYW and FC dyads. A two-arm RCT will now be conducted with about 645 AGYW (15-19 years old) and FC dyads. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (~12 hours) that includes joint and separate mother and daughter activities. AGYW and FC will complete baseline, 6-, and 12-month assessments, including testing for three STI (chlamydia, gonorrhea, and trichomoniasis). We will offer HTC and PrEP at each assessment and track uptake and linkage to care. AGYW and FC who are HIV-negative and interested in PrEP will receive a one-month supply and referral to a clinic. They will additionally receive treatment and counseling if testing positive for an STI and referral for care at an ART clinic if testing positive for HIV. Data will be collected to determine the costs of IMARA. Analyses will compare AGYW across the intervention and control programs on STI incidence, and PrEP and HTC uptake, in addition to secondary outcomes. We will also evaluate the costs and cost-effectiveness of IMARA with respect to the acquisition of STI and HIV, where possible considering power limitations. Additionally, the intervention's implementation will be explored. The study answers an urgent need to evaluate the effectiveness and cost-effectiveness of combination HIV prevention packages for AGYW.
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 intervention arm or a health promotion control arm matched in time and intensity. IMARA and the health promotion program will be delivered as group interventions.
| Arm | Type | Receives |
|---|---|---|
| IMARA intervention arm | Experimental | Behavioral: IMARA (intervention group)Participants randomized to the IMARA arm will receive the IMARA 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 (10 listed)
- female;
- 15-19 years-old;
- residing in Klipfontein/Mitchells Plain (K/MP);
- speak isiXhosa or English or a combination of these languages;
- willing to have biometric data collected.
Key exclusion criteria (3 listed)
- 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: a) unable to understand the consent/assent process and provide written informed consent; b) currently enrolled in another research study addressing HIV/STIs/PrEP.
- 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 (intervention group)The IMARA 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'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 is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk. | Behavioural | IMARA 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
Proportion of adolescent girls and young women (AGYW) with a sexually-transmitted infection (STI) at baseline and midline
Time frame: ~6 months (from baseline to midline)
A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis
Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and midline
Time frame: ~6 months (from baseline to midline)
Completion of HTC
Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and midline
Time frame: ~6 months (from baseline to midline)
Uptake of PrEP
8 secondary outcomes
Proportion of AGYW with an STI at baseline and endline
Time frame: ~12 months (from baseline to endline)
Proportion of AGYW who complete HTC at baseline and endline
Time frame: ~12 months (from baseline to endline)
Proportion of AGYW who elect to take PrEP at baseline and endline
Time frame: ~12 months (from baseline to endline)
Proportion of AGYW who report risky sexual behavior at baseline, midline, and endline
Time frame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who report adherence to PrEP at baseline, midline, and endline
Time frame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who report adherence to antiretroviral therapy (ART) at baseline, midline, and endline
Time frame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Proportion of AGYW who test positive for HIV at baseline, midline, and endline
Time frame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Intervention cost-effectiveness
Time frame: The study duration (~2.5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- 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.
- BackgroundAtujuna M, Merrill K, Ndwayana S, Emerson E, Fynn L, Bekker L-G, Donenberg G: Engaging female caregivers to improve South African girls' and young womens' sexual and reproductive health outcomes. In: HIV Research for Prevention Virtual Conference. 2021.
- 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.
- Background: PubMed 27098408Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.
- Background: PubMed 31036002Haroz EE, Bolton P, Nguyen AJ, Lee C, Bogdanov S, Bass J, Singh NS, Doty B, Murray L. Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC Health Serv Res. 2019 Apr 29;19(1):262. doi: 10.1186/s12913-019-4097-y.
- BackgroundLane KL, Bocian KM, MacMillan DL, Gresham FM. Treatment integrity: An essential-but often forgotten-component of school-based interventions. Preventing School Failure. 2004; 48(3): 36-43.
- Background: PubMed 22471965Norton WE. An exploratory study to examine intentions to adopt an evidence-based HIV linkage-to-care intervention among state health department AIDS directors in the United States. Implement Sci. 2012 Apr 2;7:27. doi: 10.1186/1748-5908-7-27.
- Derived from this study: PubMed 34847908Donenberg G, Merrill KG, Atujuna M, Emerson E, Bray B, Bekker LG. Mental health outcomes of a pilot 2-arm randomized controlled trial of a HIV-prevention program for South African adolescent girls and young women and their female caregivers. BMC Public Health. 2021 Nov 30;21(1):2189. doi: 10.1186/s12889-021-12010-1.
- Derived from this study: PubMed 34544403Donenberg GR, Atujuna M, Merrill KG, Emerson E, Ndwayana S, Blachman-Demner D, Bekker LG. An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol. BMC Public Health. 2021 Sep 20;21(1):1708. doi: 10.1186/s12889-021-11727-3.
- Individual participant dataSharing planned: Yes. De-identified data will be placed in one or more electronic databases (e.g. DASH, PATC3H) which could be used for other research studies in addition to this one.
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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 Health Foundation
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 (intervention group) in people with Sexually Transmitted Infections and HIV Infections, 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 10 inclusion and 3 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 20 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of adolescent girls and young women (AGYW) with a sexually-transmitted infection (STI) at baseline and midline (time frame: ~6 months (from baseline to midline)). 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 NCT04758390, which also lists 9 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 20 Jan 2025.