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| Name | Class |
|---|---|
| Desmond Tutu HIV Centre | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMARA-SA intervention arm | Experimental | Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMARA-SA (intervention group) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8-17 months post baseline |
| Number of AGYW Completing HIV Testing and Counseling (HTC) | Completion of HIV Testing and Counseling (HTC) | 8-17 months post baseline |
| Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP) | Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey. | 8-17 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Fidelity | Number of IMARA intervention activities completed as planned. | Same day the IMARA intervention was conducted |
| Intervention Reach | The number of dyads who were eligible and consented/assented to participate in the study. |
Inclusion criteria for AGYW include:
Inclusion criteria for FC include:
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:
Participants will be eligible to participate if they are female.
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| Name | Affiliation | Role |
|---|---|---|
| Geri R Donenberg, PhD | University of Illinois at Chicago | Principal Investigator |
| Linda-Gail Bekker, MBChB, PhD | Desmond Tutu HIV Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desmond Tutu HIV Centre | Cape Town | Western Cape | 7925 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36962830 | Derived | Merrill KG, Atujuna M, Emerson E, Blachman-Demner D, Bray BC, Bekker LG, Donenberg GR. Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial. PLOS Glob Public Health. 2023 Feb 15;3(2):e0001092. doi: 10.1371/journal.pgph.0001092. eCollection 2023. |
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Data will be available on request, pending discussion with the study team about the planned use of the data.
Following all study publications
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adolescent Girls and Young Women (AGYW, N=59) and Female Caregivers (FC, N=59) contributed data for Age, Sex, Region of Enrollment, Highest Education Achieved, and Supporting Self Financially variables. AGYW (N=59) contributed data for Type of Female Caregiver, Sexual Behavior, HIV Testing and Counseling, Sexually Transmitted Infections, Prescribed PrEP, and Adherence to PrEP variables.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | AGYW contributed to AGYW Age data, N=59 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Count of Participants | Participants | 8-17 months post baseline |
|
Data were collected from enrollment to follow-up visit (8 to 17 months post baseline).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMARA-SA Intervention Arm | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geri Donenberg | Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago | 312-996-8602 | gerid@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2020 | Dec 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF for Girls between the ages of 18-19 | Sep 21, 2020 | Dec 5, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent ICF for Minors | Sep 21, 2020 | Dec 5, 2023 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF for Caregiver's own participation | Sep 21, 2020 | Dec 5, 2023 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent for Minors | Sep 21, 2020 | Dec 5, 2023 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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|
| Health promotion control group | Behavioral | 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. |
|
| 6-10 months post baseline |
| AGYW Condom Use at Last Sex | Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA). | 6-10 months post baseline |
| AGYW Consistency of Condom Use | Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA). | 6-10 months post baseline |
| AGYW Substance Use During Sex in the Past 6 Months | Self-reported number of times had vaginal or anal sex while drinking or taking drugs in the past 6-months using the AIDS Risk Behavior Assessment (ARBA). | 6-10 months post baseline |
| Number of Partners in the Past 6 Months | Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA). | 6-10 months post baseline |
| Enrollment |
| Intervention Feasibility: Completed the First Intervention Day of IMARA | The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session | Baseline |
| Intervention Feasibility: Completed the Second Intervention Day of IMARA | The number of dyads in the IMARA-SA group who attended the second IMARA-SA session | Baseline |
| Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today? | 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. | Immediately post-intervention Day 1 and Day 2 |
| Intervention Acceptability: How Satisfied Were You With Today's Workshop? | 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. | Immediately post-intervention Day 1 and Day 2 |
| 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. | Immediately post-intervention Day 1 and Day 2 |
| Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said? | 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. | Immediately post-intervention Day 1 and Day 2 |
| Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop? | 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. | Immediately post-intervention Day 1 and Day 2 |
| Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities? | 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. | Immediately post-intervention Day 1 and Day 2 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Customized | FC contributed to FC Age data, N=59 | Count of Participants | Participants | No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| AGYW highest education achieved | AGYW contributed to AGYW highest education achieved data, N=59 | Count of Participants | Participants | No |
|
| FC highest education level acheived | FC contributed to FC highest education achieved data, N=59 | Count of Participants | Participants |
|
| AGYW supported self financially in past year | AGYW contributed to AGYW supported self financially in past year data, N=59 | Count of Participants | Participants | No |
|
| FC supported self financially in the past year | FC contributed to FC supported self financially in the past year data, N=59 | Count of Participants | Participants |
|
| AGYW report of female caregiver participating | AGYW contributed to AGYW report of female caregiver participating data, N=59 | Count of Participants | Participants | No |
|
| Number of AGYW reporting ever had sex | Sex is defined as vaginal or anal sex. | AGYW contributed to Number of AGYW reporting ever had sex data, N=59 | Count of Participants | Participants | No |
|
| Number of AGYW who have had sex in past 6 months | Among AGYW who have ever had sex (n=39). | Count of Participants | Participants | No |
|
| AGYW age at first sex | Among AGYW who have ever had sex (n=39). | Mean | Standard Deviation | years |
|
| Number of AGYW reporting did not use a condom at last sex | Among AGYW who had sex in the past 6 months (n=26). | Count of Participants | Participants | No |
|
| Number of AGYW who report using condoms inconsistently in past 6 months | Among AGYW who had sex in the past 6 months (n=26). | Count of Participants | Participants | No |
|
| Number of AGYW who report using substances during sex in past 6 months | Among AGYW who had sex in the past 6 months (n=26). | Count of Participants | Participants | No |
|
| Number of AGYW who report 2 or more partners in the past 6 months | Among AGYW who had sex in the past 6 months (n=26). | Count of Participants | Participants | No |
|
| Number of AGYW Completing HIV Testing and Counseling (HTC) | Among AGYW who were not living with HIV at baseline (n=57). | Count of Participants | Participants |
|
| Number of AGYW who tested positive for a Sexually Transmitted Infection (STI) | Among AGYW who completed STI testing (gonorrhea and/or chlamydia) at baseline (n=56). | Count of Participants | Participants |
|
| Number of AGYW who were ever prescribed PrEP | AGYW contributed to Number of AGYW who were ever prescribed PrEP data, N=59 | Count of Participants | Participants | No |
|
| AGYW's Report of Adherence to PrEP | (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. | Among AGYW who self-reported having ever been prescribed PrEP at baseline. | Mean | Standard Deviation | score |
|
| OG001 | 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. |
|
|
|
| Primary | Number of AGYW Completing HIV Testing and Counseling (HTC) | Completion of HIV Testing and Counseling (HTC) | 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). | Posted | Count of Participants | Participants | 8-17 months post baseline |
|
|
|
| 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. | Denominator is those who completed follow-up surveys, were not living with HIV, and did not report having been prescribed PrEP at baseline. | Posted | Count of Participants | Participants | 8-17 months post baseline |
|
|
|
|
| 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. | Denominator is those who reported being prescribed PrEP on the follow-up survey and not on the baseline survey. | Posted | Mean | Standard Deviation | score on a scale | 6-10 months post baseline |
|
|
|
|
| Secondary | AGYW Condom Use at Last Sex | Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA). | Denominator includes AGYW who reported sex in the past 6 months at follow-up. | Posted | Count of Participants | Participants | 6-10 months post baseline |
|
|
|
|
| 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). | Posted | Count of Participants | Participants | 6-10 months post baseline |
|
|
|
|
| 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). | Posted | Count of Participants | Participants | 6-10 months post baseline |
|
|
|
|
| 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). | Posted | Count of Participants | Participants | 6-10 months post baseline |
|
|
|
|
| Other Pre-specified | Intervention Fidelity | Number of IMARA intervention activities completed as planned. | 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. | Posted | Number | Number of IMARA intervention activities | Same day the IMARA intervention was conducted | Activities | Activities |
|
|
|
| Other Pre-specified | Intervention Reach | The number of dyads who were eligible and consented/assented to participate in the study. | Data represents number of dyads who were eligible and enrolled. | Posted | Count of Participants | Participants | Enrollment |
|
|
|
| Other Pre-specified | Intervention Feasibility: Completed the First Intervention Day of IMARA | 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 | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Intervention Feasibility: Completed the Second Intervention Day of IMARA | 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 | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today? | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| Other Pre-specified | Intervention Acceptability: How Satisfied Were You With Today's Workshop? | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| Other Pre-specified | Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said? | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| Other Pre-specified | Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop? | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| Other Pre-specified | Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities? | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-intervention Day 1 and Day 2 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 40-49 years old |
|
| 50 and older |
|
| Missing Data |
|
| Higher education |
|
| Some or all of secondary |
|
| Higher education |
|
| Missing Data |
|
| Sister |
|
| Cousin |
|
| Grandmother |
|
| Other |
|
| FC Day 1 |
|
|
| AGYW Day 2 |
|
|
| FC Day 2 |
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| FC Day 1 |
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| AGYW Day 2 |
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| FC Day 2 |
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| FC Day 1 |
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| AGYW Day 2 |
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| FC Day 2 |
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| FC Day 1 |
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| AGYW Day 2 |
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| FC Day 2 |
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| FC Day 1 |
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| AGYW Day 2 |
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| FC Day 2 |
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| FC Day 1 |
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| AGYW Day 2 |
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| FC Day 2 |
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