A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA

Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05504954

Acronym

IMARA-SA pilot

Enrollment

Registered

2022-08-17

Start date

2019-10-26

Completion date

2021-05-15

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Sexually Transmitted Infection

Keywords

HIV prevention, Adolescent girls and young women, South Africa, Mother-daughter intervention

Brief 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. 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.

Interventions

BEHAVIORALIMARA-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.

BEHAVIORALHealth promotion control group

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 19 Years

Healthy volunteers

Yes

Inclusion criteria

for AGYW include: 1. Black or mixed race; 2. 15-19 years-old; 3. residing in Klipfontein/Mitchells Plain (K/MP); 4. speak isiXhosa or English or a combination of these languages. Inclusion criteria for FC include: 1. identified by AGYW as a FC; 2. 24 years and older; 3. living with or in daily contact with the AGYW; 4. speak isiXhosa or English or a combination of these languages.

Exclusion criteria

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: 1. are unable to understand the consent/assent process and provide written informed consent; 2. are currently enrolled in another research study addressing HIV/STIs/PrEP; 3. participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.

Design outcomes

Primary

Measure	Time frame	Description
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)	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)	8-17 months post baseline	Completion of HIV Testing and Counseling (HTC)
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)	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.

Secondary

Measure	Time frame	Description
AGYW Substance Use During Sex in the Past 6 Months	6-10 months post baseline	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).
AGYW's Report of Adherence to PrEP	6-10 months post baseline	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.
Number of Partners in the Past 6 Months	6-10 months post baseline	Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
AGYW Condom Use at Last Sex	6-10 months post baseline	Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).
AGYW Consistency of Condom Use	6-10 months post baseline	Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).

Other

Measure	Time frame	Description
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?	Immediately post-intervention Day 1 and Day 2	Single item: How honest did you feel you could be during today's workshop? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.
Intervention Fidelity	Same day the IMARA intervention was conducted	Number of IMARA intervention activities completed as planned.
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?	Immediately post-intervention Day 1 and Day 2	Single item: How much did you feel you were involved or engaged in the activities? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.
Intervention Reach	Enrollment	The number of dyads who were eligible and consented/assented to participate in the study.
Intervention Feasibility: Completed the First Intervention Day of IMARA	Baseline	The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session
Intervention Feasibility: Completed the Second Intervention Day of IMARA	Baseline	The number of dyads in the IMARA-SA group who attended the second IMARA-SA session
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?	Immediately post-intervention Day 1 and Day 2	Single item: How knowledgeable were your group leaders about the information presented today? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.
Intervention Acceptability: How Satisfied Were You With Today's Workshop?	Immediately post-intervention Day 1 and Day 2	Single item: How satisfied were you with today's workshop? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?	Immediately post-intervention Day 1 and Day 2	Single item: How comfortable were you with the group leaders who worked with you today? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?	Immediately post-intervention Day 1 and Day 2	Single item: How much did you feel the group leaders valued what you said? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.

Countries

South Africa

Participant flow

Pre-assignment details

61 dyads were enrolled. Two dyads were withdrawn due to ineligibility. A total of 118 participants (59 dyads) were allocated to either IMARA-SA or the Health Promotion Control Arm.

Participants by arm

Arm	Count
IMARA-SA Intervention Arm 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.	58
Health Promotion Control Arm Health promotion control group: 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.	60
Total	118

Baseline characteristics

Characteristic	Health Promotion Control Arm	IMARA-SA Intervention Arm	Total
Age, Customized AGYW Age 15-17 years old	17 Participants	17 Participants	34 Participants
Age, Customized AGYW Age 18-19 years old	13 Participants	12 Participants	25 Participants
Age, Customized FC Age 24-29 years old	6 Participants	11 Participants	17 Participants
Age, Customized FC Age 30-39 years old	13 Participants	9 Participants	22 Participants
Age, Customized FC Age 40-49 years old	7 Participants	7 Participants	14 Participants
Age, Customized FC Age 50 and older	3 Participants	2 Participants	5 Participants
Age, Customized FC Age Missing Data	1 Participants	0 Participants	1 Participants
AGYW age at first sex	15.7 years STANDARD_DEVIATION 0.93	15.6 years STANDARD_DEVIATION 1.1	15.6 years STANDARD_DEVIATION 1.01
AGYW highest education achieved Higher education	4 Participants	0 Participants	4 Participants
AGYW highest education achieved Some or all of primary school	11 Participants	11 Participants	22 Participants
AGYW highest education achieved Some or all of secondary	15 Participants	18 Participants	33 Participants
AGYW report of female caregiver participating Aunt	10 Participants	6 Participants	16 Participants
AGYW report of female caregiver participating Biological mother	12 Participants	12 Participants	24 Participants
AGYW report of female caregiver participating Cousin	2 Participants	3 Participants	5 Participants
AGYW report of female caregiver participating Grandmother	1 Participants	0 Participants	1 Participants
AGYW report of female caregiver participating Other	1 Participants	1 Participants	2 Participants
AGYW report of female caregiver participating Sister	4 Participants	7 Participants	11 Participants
AGYW's Report of Adherence to PrEP	69.1 score STANDARD_DEVIATION 21.1	75.0 score STANDARD_DEVIATION 14.9	70.8 score STANDARD_DEVIATION 18.5
AGYW supported self financially in past year	7 Participants	3 Participants	10 Participants
FC highest education level acheived Higher education	3 Participants	4 Participants	7 Participants
FC highest education level acheived Missing Data	1 Participants	0 Participants	1 Participants
FC highest education level acheived No schooling	2 Participants	3 Participants	5 Participants
FC highest education level acheived Some or all of primary school	12 Participants	9 Participants	21 Participants
FC highest education level acheived Some or all of secondary	12 Participants	13 Participants	25 Participants
FC supported self financially in the past year	24 Participants	23 Participants	47 Participants
Number of AGYW Completing HIV Testing and Counseling (HTC)	28 Participants	28 Participants	56 Participants
Number of AGYW reporting did not use a condom at last sex	7 Participants	4 Participants	11 Participants
Number of AGYW reporting ever had sex	19 Participants	20 Participants	39 Participants
Number of AGYW who have had sex in past 6 months	14 Participants	12 Participants	26 Participants
Number of AGYW who report 2 or more partners in the past 6 months	5 Participants	5 Participants	10 Participants
Number of AGYW who report using condoms inconsistently in past 6 months	10 Participants	4 Participants	14 Participants
Number of AGYW who report using substances during sex in past 6 months	10 Participants	8 Participants	18 Participants
Number of AGYW who tested positive for a Sexually Transmitted Infection (STI)	9 Participants	12 Participants	21 Participants
Number of AGYW who were ever prescribed PrEP	5 Participants	2 Participants	7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment South Africa	60 participants	58 participants	118 participants
Sex: Female, Male Female	60 Participants	58 Participants	118 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 30
other Total, other adverse events	0 / 29	0 / 30
serious Total, serious adverse events	0 / 29	0 / 30

Outcome results

Primary

Number of AGYW Completing HIV Testing and Counseling (HTC)

Completion of HIV Testing and Counseling (HTC)

Time frame: 8-17 months post baseline

Population: Denominator is those who came to site for HTC at follow-up and were not living with HIV (39 came to site for follow-up, 2 were living with HIV and were removed).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	Number of AGYW Completing HIV Testing and Counseling (HTC)	20 Participants
Health Promotion Control Arm	Number of AGYW Completing HIV Testing and Counseling (HTC)	17 Participants

Primary

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.

Time frame: 8-17 months post baseline

Population: Denominator is those who completed follow-up surveys, were not living with HIV, and did not report having been prescribed PrEP at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)	17 Participants
Health Promotion Control Arm	Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)	9 Participants

p-value: 0.195% CI: [0.81, 9.89]Regression, Logistic

Primary

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

Time frame: 8-17 months post baseline

Population: Data represents AGYW. Denominator is those who completed STI testing at follow-up. Excludes one participant who completed STI testing at follow-up but did not receive STI treatment at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)	4 Participants
Health Promotion Control Arm	Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)	6 Participants

p-value: 0.1595% CI: [0.04, 1.59]Regression, Logistic

Secondary

AGYW Condom Use at Last Sex

Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).

Time frame: 6-10 months post baseline

Population: Denominator includes AGYW who reported sex in the past 6 months at follow-up.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	AGYW Condom Use at Last Sex	Yes	10 Participants
IMARA-SA Intervention Arm	AGYW Condom Use at Last Sex	No	8 Participants
Health Promotion Control Arm	AGYW Condom Use at Last Sex	Yes	4 Participants
Health Promotion Control Arm	AGYW Condom Use at Last Sex	No	5 Participants

p-value: 0.7Fisher Exact

Secondary

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).

Time frame: 6-10 months post baseline

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	AGYW Consistency of Condom Use	Always	10 Participants
IMARA-SA Intervention Arm	AGYW Consistency of Condom Use	Less than always	8 Participants
Health Promotion Control Arm	AGYW Consistency of Condom Use	Always	4 Participants
Health Promotion Control Arm	AGYW Consistency of Condom Use	Less than always	5 Participants

p-value: 0.7Fisher Exact

Secondary

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.

Time frame: 6-10 months post baseline

Population: Denominator is those who reported being prescribed PrEP on the follow-up survey and not on the baseline survey.

Arm	Measure	Value (MEAN)	Dispersion
IMARA-SA Intervention Arm	AGYW's Report of Adherence to PrEP	60.7 score on a scale	Standard Deviation 19.5
Health Promotion Control Arm	AGYW's Report of Adherence to PrEP	54.4 score on a scale	Standard Deviation 30.8

p-value: 0.6595% CI: [-17.78, 27.78]Regression, Linear

Secondary

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).

Time frame: 6-10 months post baseline

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	AGYW Substance Use During Sex in the Past 6 Months	Never	9 Participants
IMARA-SA Intervention Arm	AGYW Substance Use During Sex in the Past 6 Months	1+ time	9 Participants
Health Promotion Control Arm	AGYW Substance Use During Sex in the Past 6 Months	Never	4 Participants
Health Promotion Control Arm	AGYW Substance Use During Sex in the Past 6 Months	1+ time	5 Participants

p-value: 1Fisher Exact

Secondary

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).

Time frame: 6-10 months post baseline

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
IMARA-SA Intervention Arm	Number of Partners in the Past 6 Months	1 partner	14 Participants
IMARA-SA Intervention Arm	Number of Partners in the Past 6 Months	2+ partners	4 Participants
Health Promotion Control Arm	Number of Partners in the Past 6 Months	1 partner	8 Participants
Health Promotion Control Arm	Number of Partners in the Past 6 Months	2+ partners	1 Participants

p-value: 0.64Fisher Exact

Other Pre-specified

Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?

Single item: How comfortable were you with the group leaders who worked with you today? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.