Trial Outcomes & Findings for A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA (NCT NCT05504954)
NCT ID: NCT05504954
Last Updated: 2025-08-22
Results Overview
A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
8-17 months post baseline
Results posted on
2025-08-22
Participant Flow
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 Two dyads were withdrawn due to ineligibility.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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
Number of Dyads Completing Intervention Day 1
|
26
|
28
|
|
Overall Study
Number of Dyads Completing Intervention Day 2
|
22
|
27
|
|
Overall Study
Number of AGYW Completing at Least One Primary Outcome Measure
|
20
|
19
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AGYW contributed to AGYW Age data, N=59
Baseline characteristics by cohort
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
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.
|
Health Promotion Control Arm
n=60 Participants
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.
|
Total
n=118 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Customized
AGYW Age · 15-17 years old
|
17 Participants
n=29 Participants • AGYW contributed to AGYW Age data, N=59
|
17 Participants
n=30 Participants • AGYW contributed to AGYW Age data, N=59
|
34 Participants
n=59 Participants • AGYW contributed to AGYW Age data, N=59
|
|
Age, Customized
AGYW Age · 18-19 years old
|
12 Participants
n=29 Participants • AGYW contributed to AGYW Age data, N=59
|
13 Participants
n=30 Participants • AGYW contributed to AGYW Age data, N=59
|
25 Participants
n=59 Participants • AGYW contributed to AGYW Age data, N=59
|
|
Age, Customized
FC Age · 24-29 years old
|
11 Participants
n=29 Participants • FC contributed to FC Age data, N=59
|
6 Participants
n=30 Participants • FC contributed to FC Age data, N=59
|
17 Participants
n=59 Participants • FC contributed to FC Age data, N=59
|
|
Age, Customized
FC Age · 30-39 years old
|
9 Participants
n=29 Participants • FC contributed to FC Age data, N=59
|
13 Participants
n=30 Participants • FC contributed to FC Age data, N=59
|
22 Participants
n=59 Participants • FC contributed to FC Age data, N=59
|
|
Age, Customized
FC Age · 40-49 years old
|
7 Participants
n=29 Participants • FC contributed to FC Age data, N=59
|
7 Participants
n=30 Participants • FC contributed to FC Age data, N=59
|
14 Participants
n=59 Participants • FC contributed to FC Age data, N=59
|
|
Age, Customized
FC Age · 50 and older
|
2 Participants
n=29 Participants • FC contributed to FC Age data, N=59
|
3 Participants
n=30 Participants • FC contributed to FC Age data, N=59
|
5 Participants
n=59 Participants • FC contributed to FC Age data, N=59
|
|
Age, Customized
FC Age · Missing Data
|
0 Participants
n=29 Participants • FC contributed to FC Age data, N=59
|
1 Participants
n=30 Participants • FC contributed to FC Age data, N=59
|
1 Participants
n=59 Participants • FC contributed to FC Age data, N=59
|
|
Sex: Female, Male
Female
|
58 Participants
n=58 Participants
|
60 Participants
n=60 Participants
|
118 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=58 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=118 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Africa
|
58 participants
n=58 Participants
|
60 participants
n=60 Participants
|
118 participants
n=118 Participants
|
|
AGYW highest education achieved
Some or all of primary school
|
11 Participants
n=29 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
11 Participants
n=30 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
22 Participants
n=59 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
|
AGYW highest education achieved
Some or all of secondary
|
18 Participants
n=29 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
15 Participants
n=30 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
33 Participants
n=59 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
|
AGYW highest education achieved
Higher education
|
0 Participants
n=29 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
4 Participants
n=30 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
4 Participants
n=59 Participants • AGYW contributed to AGYW highest education achieved data, N=59
|
|
FC highest education level acheived
No schooling
|
3 Participants
n=29 Participants • FC contributed to FC highest education achieved data, N=59
|
2 Participants
n=30 Participants • FC contributed to FC highest education achieved data, N=59
|
5 Participants
n=59 Participants • FC contributed to FC highest education achieved data, N=59
|
|
FC highest education level acheived
Some or all of primary school
|
9 Participants
n=29 Participants • FC contributed to FC highest education achieved data, N=59
|
12 Participants
n=30 Participants • FC contributed to FC highest education achieved data, N=59
|
21 Participants
n=59 Participants • FC contributed to FC highest education achieved data, N=59
|
|
FC highest education level acheived
Some or all of secondary
|
13 Participants
n=29 Participants • FC contributed to FC highest education achieved data, N=59
|
12 Participants
n=30 Participants • FC contributed to FC highest education achieved data, N=59
|
25 Participants
n=59 Participants • FC contributed to FC highest education achieved data, N=59
|
|
FC highest education level acheived
Higher education
|
4 Participants
n=29 Participants • FC contributed to FC highest education achieved data, N=59
|
3 Participants
n=30 Participants • FC contributed to FC highest education achieved data, N=59
|
7 Participants
n=59 Participants • FC contributed to FC highest education achieved data, N=59
|
|
FC highest education level acheived
Missing Data
|
0 Participants
n=29 Participants • FC contributed to FC highest education achieved data, N=59
|
1 Participants
n=30 Participants • FC contributed to FC highest education achieved data, N=59
|
1 Participants
n=59 Participants • FC contributed to FC highest education achieved data, N=59
|
|
AGYW supported self financially in past year
|
3 Participants
n=29 Participants • AGYW contributed to AGYW supported self financially in past year data, N=59
|
7 Participants
n=30 Participants • AGYW contributed to AGYW supported self financially in past year data, N=59
|
10 Participants
n=59 Participants • AGYW contributed to AGYW supported self financially in past year data, N=59
|
|
FC supported self financially in the past year
|
23 Participants
n=29 Participants • FC contributed to FC supported self financially in the past year data, N=59
|
24 Participants
n=30 Participants • FC contributed to FC supported self financially in the past year data, N=59
|
47 Participants
n=59 Participants • FC contributed to FC supported self financially in the past year data, N=59
|
|
AGYW report of female caregiver participating
Biological mother
|
12 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
12 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
24 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
AGYW report of female caregiver participating
Aunt
|
6 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
10 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
16 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
AGYW report of female caregiver participating
Sister
|
7 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
4 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
11 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
AGYW report of female caregiver participating
Cousin
|
3 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
2 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
5 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
AGYW report of female caregiver participating
Grandmother
|
0 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
1 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
1 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
AGYW report of female caregiver participating
Other
|
1 Participants
n=29 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
1 Participants
n=30 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
2 Participants
n=59 Participants • AGYW contributed to AGYW report of female caregiver participating data, N=59
|
|
Number of AGYW reporting ever had sex
|
20 Participants
n=29 Participants • AGYW contributed to Number of AGYW reporting ever had sex data, N=59
|
19 Participants
n=30 Participants • AGYW contributed to Number of AGYW reporting ever had sex data, N=59
|
39 Participants
n=59 Participants • AGYW contributed to Number of AGYW reporting ever had sex data, N=59
|
|
Number of AGYW who have had sex in past 6 months
|
12 Participants
n=20 Participants • Among AGYW who have ever had sex (n=39).
|
14 Participants
n=19 Participants • Among AGYW who have ever had sex (n=39).
|
26 Participants
n=39 Participants • Among AGYW who have ever had sex (n=39).
|
|
AGYW age at first sex
|
15.6 years
STANDARD_DEVIATION 1.10 • n=20 Participants • Among AGYW who have ever had sex (n=39).
|
15.7 years
STANDARD_DEVIATION 0.93 • n=19 Participants • Among AGYW who have ever had sex (n=39).
|
15.6 years
STANDARD_DEVIATION 1.01 • n=39 Participants • Among AGYW who have ever had sex (n=39).
|
|
Number of AGYW reporting did not use a condom at last sex
|
4 Participants
n=12 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
7 Participants
n=14 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
11 Participants
n=26 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
|
Number of AGYW who report using condoms inconsistently in past 6 months
|
4 Participants
n=12 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
10 Participants
n=14 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
14 Participants
n=26 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
|
Number of AGYW who report using substances during sex in past 6 months
|
8 Participants
n=12 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
10 Participants
n=14 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
18 Participants
n=26 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
|
Number of AGYW who report 2 or more partners in the past 6 months
|
5 Participants
n=12 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
5 Participants
n=14 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
10 Participants
n=26 Participants • Among AGYW who had sex in the past 6 months (n=26).
|
|
Number of AGYW Completing HIV Testing and Counseling (HTC)
|
28 Participants
n=29 Participants • Among AGYW who were not living with HIV at baseline (n=57).
|
28 Participants
n=28 Participants • Among AGYW who were not living with HIV at baseline (n=57).
|
56 Participants
n=57 Participants • Among AGYW who were not living with HIV at baseline (n=57).
|
|
Number of AGYW who tested positive for a Sexually Transmitted Infection (STI)
|
12 Participants
n=28 Participants • Among AGYW who completed STI testing (gonorrhea and/or chlamydia) at baseline (n=56).
|
9 Participants
n=28 Participants • Among AGYW who completed STI testing (gonorrhea and/or chlamydia) at baseline (n=56).
|
21 Participants
n=56 Participants • Among AGYW who completed STI testing (gonorrhea and/or chlamydia) at baseline (n=56).
|
|
Number of AGYW who were ever prescribed PrEP
|
2 Participants
n=29 Participants • AGYW contributed to Number of AGYW who were ever prescribed PrEP data, N=59
|
5 Participants
n=30 Participants • AGYW contributed to Number of AGYW who were ever prescribed PrEP data, N=59
|
7 Participants
n=59 Participants • AGYW contributed to Number of AGYW who were ever prescribed PrEP data, N=59
|
|
AGYW's Report of Adherence to PrEP
|
75.0 score
STANDARD_DEVIATION 14.9 • n=2 Participants • Among AGYW who self-reported having ever been prescribed PrEP at baseline.
|
69.1 score
STANDARD_DEVIATION 21.1 • n=5 Participants • Among AGYW who self-reported having ever been prescribed PrEP at baseline.
|
70.8 score
STANDARD_DEVIATION 18.5 • n=7 Participants • Among AGYW who self-reported having ever been prescribed PrEP at baseline.
|
PRIMARY outcome
Timeframe: 8-17 months post baselinePopulation: 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.
A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=18 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=16 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 8-17 months post baselinePopulation: 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).
Completion of HIV Testing and Counseling (HTC)
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=20 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=17 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Number of AGYW Completing HIV Testing and Counseling (HTC)
|
20 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 8-17 months post baselinePopulation: Denominator is those who completed follow-up surveys, were not living with HIV, and did not report having been prescribed PrEP at baseline.
Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=25 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=20 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6-10 months post baselinePopulation: Denominator is those who reported being prescribed PrEP on the follow-up survey and not on the baseline survey.
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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=14 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=7 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
AGYW's Report of Adherence to PrEP
|
60.7 score on a scale
Standard Deviation 19.5
|
54.4 score on a scale
Standard Deviation 30.8
|
SECONDARY outcome
Timeframe: 6-10 months post baselinePopulation: Denominator includes AGYW who reported sex in the past 6 months at follow-up.
Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=18 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=9 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
AGYW Condom Use at Last Sex
Yes
|
10 Participants
|
4 Participants
|
|
AGYW Condom Use at Last Sex
No
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6-10 months post baselineSelf-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=18 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=9 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
AGYW Consistency of Condom Use
Always
|
10 Participants
|
4 Participants
|
|
AGYW Consistency of Condom Use
Less than always
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6-10 months post baselineSelf-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).
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=18 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=9 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
AGYW Substance Use During Sex in the Past 6 Months
Never
|
9 Participants
|
4 Participants
|
|
AGYW Substance Use During Sex in the Past 6 Months
1+ time
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6-10 months post baselineSelf-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=18 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=9 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Number of Partners in the Past 6 Months
1 partner
|
14 Participants
|
8 Participants
|
|
Number of Partners in the Past 6 Months
2+ partners
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Same day the IMARA intervention was conductedPopulation: Proportion of IMARA intervention activities completed as planned. Fidelity was not measured for the health promotion control group. The number of units analyzed is the total number of activities in the IMARA intervention.
Number of IMARA intervention activities completed as planned.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=210 Activities
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Fidelity
|
199 Number of IMARA intervention activities
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: EnrollmentPopulation: Data represents number of dyads who were eligible and enrolled.
The number of dyads who were eligible and consented/assented to participate in the study.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=59 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Reach
|
59 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session
The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=29 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Feasibility: Completed the First Intervention Day of IMARA
|
26 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The number of dyads in the IMARA-SA group who attended the second IMARA-SA session
The number of dyads in the IMARA-SA group who attended the second IMARA-SA session
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=29 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Feasibility: Completed the Second Intervention Day of IMARA
|
22 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1 and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?
AGYW Day 1
|
4.90 units on a scale
Standard Deviation .31
|
4.86 units on a scale
Standard Deviation .45
|
|
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?
FC Day 1
|
4.88 units on a scale
Standard Deviation .33
|
4.75 units on a scale
Standard Deviation .59
|
|
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?
AGYW Day 2
|
4.73 units on a scale
Standard Deviation .55
|
4.80 units on a scale
Standard Deviation .41
|
|
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?
FC Day 2
|
4.86 units on a scale
Standard Deviation .36
|
4.88 units on a scale
Standard Deviation .34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1 and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Satisfied Were You With Today's Workshop?
AGYW Day 1
|
4.95 units on a scale
Standard Deviation .22
|
4.54 units on a scale
Standard Deviation .69
|
|
Intervention Acceptability: How Satisfied Were You With Today's Workshop?
FC Day 1
|
4.85 units on a scale
Standard Deviation .37
|
4.79 units on a scale
Standard Deviation .50
|
|
Intervention Acceptability: How Satisfied Were You With Today's Workshop?
AGYW Day 2
|
4.86 units on a scale
Standard Deviation .35
|
4.80 units on a scale
Standard Deviation .58
|
|
Intervention Acceptability: How Satisfied Were You With Today's Workshop?
FC Day 2
|
4.76 units on a scale
Standard Deviation .44
|
5.00 units on a scale
Standard Deviation .00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1 and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?
AGYW Day 1
|
4.65 units on a scale
Standard Deviation .49
|
4.89 units on a scale
Standard Deviation .32
|
|
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?
FC Day 1
|
4.73 units on a scale
Standard Deviation .53
|
4.79 units on a scale
Standard Deviation .50
|
|
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?
AGYW Day 2
|
4.68 units on a scale
Standard Deviation .57
|
4.80 units on a scale
Standard Deviation .41
|
|
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?
FC Day 2
|
4.90 units on a scale
Standard Deviation .30
|
4.96 units on a scale
Standard Deviation .20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1 and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?
AGYW Day 1
|
4.75 units on a scale
Standard Deviation .55
|
4.79 units on a scale
Standard Deviation .42
|
|
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?
FC Day 1
|
4.88 units on a scale
Standard Deviation .33
|
4.79 units on a scale
Standard Deviation .57
|
|
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?
AGYW Day 2
|
4.68 units on a scale
Standard Deviation .57
|
4.76 units on a scale
Standard Deviation .44
|
|
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?
FC Day 2
|
4.95 units on a scale
Standard Deviation .22
|
4.88 units on a scale
Standard Deviation .34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1 and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?
AGYW Day 1
|
4.70 units on a scale
Standard Deviation .57
|
4.64 units on a scale
Standard Deviation .56
|
|
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?
FC Day 1
|
4.69 units on a scale
Standard Deviation .62
|
4.82 units on a scale
Standard Deviation .39
|
|
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?
AGYW Day 2
|
4.73 units on a scale
Standard Deviation .55
|
4.80 units on a scale
Standard Deviation .50
|
|
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?
FC Day 2
|
4.86 units on a scale
Standard Deviation .36
|
5.00 units on a scale
Standard Deviation .00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-intervention Day 1 and Day 2Population: 29 AGYW-FC dyads were randomized to IMARA-SA: 26 dyads completed Day 1 and 22 dyads completed Day 2. Data is missing for 6 AGYW who completed Day 1, 1 AGYW who completed Day 2, and 1 FC who completed Day 2. 30 AGYW-FC dyads were randomized to Health Promotion: 28 dyads completed Day 1 and 27 dyads completed Day 2. Data is missing for 2 AGYW and 3 FC who completed 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.
Outcome measures
| Measure |
IMARA-SA Intervention Arm
n=58 Participants
Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
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.
|
Health Promotion Control Arm
n=60 Participants
Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
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.
|
|---|---|---|
|
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?
AGYW Day 1
|
4.75 units on a scale
Standard Deviation .44
|
4.71 units on a scale
Standard Deviation .60
|
|
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?
FC Day 1
|
4.58 units on a scale
Standard Deviation .64
|
4.68 units on a scale
Standard Deviation .61
|
|
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?
AGYW Day 2
|
4.67 units on a scale
Standard Deviation .58
|
4.72 units on a scale
Standard Deviation .54
|
|
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?
FC Day 2
|
4.95 units on a scale
Standard Deviation .22
|
4.75 units on a scale
Standard Deviation .61
|
Adverse Events
IMARA-SA Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Promotion Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Geri Donenberg
Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago
Phone: 312-996-8602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place