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

NCT04758390 | Completed DMC

• 2 other identifiers: 2018-0709UH3HD096875
• Study Type: interventional
• Target: 1,290
• Locations: 1 country
• Sites: 1

Brief Summary

To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.

Conditions

Sexually Transmitted Infections; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Proportion of adolescent girls and young women (AGYW) with a sexually-transmitted infection (STI) at baseline and midline

  A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis

  ~6 months (from baseline to midline)

• Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and midline

  Completion of HTC

  ~6 months (from baseline to midline)

• Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and midline

  Uptake of PrEP

  ~6 months (from baseline to midline)

Secondary Outcomes (8)

• Proportion of AGYW with an STI at baseline and endline

  ~12 months (from baseline to endline)

• Proportion of AGYW who complete HTC at baseline and endline

  ~12 months (from baseline to endline)

• Proportion of AGYW who elect to take PrEP at baseline and endline

  ~12 months (from baseline to endline)

• Proportion of AGYW who report risky sexual behavior at baseline, midline, and endline

  ~6 months (from baseline to midline) and ~12 months (from baseline to endline)

• Proportion of AGYW who report adherence to PrEP at baseline, midline, and endline

  ~6 months (from baseline to midline) and ~12 months (from baseline to endline)

Other Outcomes (11)

• Proportion of female caregivers (FC) with an STI at baseline, midline, and endline

  ~6 months (from baseline to midline) and ~12 months (from baseline to endline)

• Proportion of FC who complete HTC at baseline, midline, and endline

  ~6 months (from baseline to midline) and ~12 months (from baseline to endline)

• Proportion of FC who elect to take PrEP baseline, midline, and endline

  ~6 months (from baseline to midline) and ~12 months (from baseline to endline)

Study Arms (2)

IMARA intervention arm

EXPERIMENTAL

Participants randomized to the IMARA arm will receive the IMARA intervention (i.e., the intervention group).

Behavioral: IMARA (intervention group)

Health promotion control arm

EXPERIMENTAL

Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).

Behavioral: Health promotion control group

Interventions

IMARA (intervention group) BEHAVIORAL

The IMARA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.

IMARA intervention arm

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.

Health promotion control arm

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Participants will be eligible to participate if they are female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• female;
• years-old;
• residing in Klipfontein/Mitchells Plain (K/MP);
• speak isiXhosa or English or a combination of these languages;
• willing to have biometric data collected.
• identified by AGYW as a FC;
• years and older;
• living with or in daily contact with the AGYW;
• speak isiXhosa or English or a combination of these languages;
• willing to have biometric data collected.

You may not qualify if:

• AGYW will be excluded from the study if they do not have a FC to participate in the study.
• AGYW and FC will be excluded from the study if they are: a) unable to understand the consent/assent process and provide written informed consent; b) currently enrolled in another research study addressing HIV/STIs/PrEP.
• AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Desmond Tutu Health Foundation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Desmond Tutu Health Foundation

Cape Town, 7925, South Africa

Location

Related Publications (9)

• Donenberg GR, Kendall AD, Emerson E, Fletcher FE, Bray BC, McCabe K. IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents. PLoS One. 2020 Nov 2;15(11):e0239650. doi: 10.1371/journal.pone.0239650. eCollection 2020.

  PMID: 33137103 BACKGROUND

• Atujuna M, Merrill K, Ndwayana S, Emerson E, Fynn L, Bekker L-G, Donenberg G: Engaging female caregivers to improve South African girls' and young womens' sexual and reproductive health outcomes. In: HIV Research for Prevention Virtual Conference. 2021.

  BACKGROUND

• Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642-53. doi: 10.1097/00004583-200106000-00008.

  PMID: 11392341 BACKGROUND

• Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.

  PMID: 27098408 BACKGROUND

• Haroz EE, Bolton P, Nguyen AJ, Lee C, Bogdanov S, Bass J, Singh NS, Doty B, Murray L. Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC Health Serv Res. 2019 Apr 29;19(1):262. doi: 10.1186/s12913-019-4097-y.

  PMID: 31036002 BACKGROUND

• Lane KL, Bocian KM, MacMillan DL, Gresham FM. Treatment integrity: An essential-but often forgotten-component of school-based interventions. Preventing School Failure. 2004; 48(3): 36-43.

  BACKGROUND

• Norton WE. An exploratory study to examine intentions to adopt an evidence-based HIV linkage-to-care intervention among state health department AIDS directors in the United States. Implement Sci. 2012 Apr 2;7:27. doi: 10.1186/1748-5908-7-27.

  PMID: 22471965 BACKGROUND

• Donenberg G, Merrill KG, Atujuna M, Emerson E, Bray B, Bekker LG. Mental health outcomes of a pilot 2-arm randomized controlled trial of a HIV-prevention program for South African adolescent girls and young women and their female caregivers. BMC Public Health. 2021 Nov 30;21(1):2189. doi: 10.1186/s12889-021-12010-1.

  PMID: 34847908 DERIVED

• Donenberg GR, Atujuna M, Merrill KG, Emerson E, Ndwayana S, Blachman-Demner D, Bekker LG. An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol. BMC Public Health. 2021 Sep 20;21(1):1708. doi: 10.1186/s12889-021-11727-3.

  PMID: 34544403 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; HIV Infections

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Geri R Donenberg, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu Health Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Human Development Nursing Science

Model Details: Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA intervention arm or a health promotion control arm matched in time and intensity. IMARA and the health promotion program will be delivered as group interventions.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: October 2, 2021
• Primary Completion: April 7, 2024
• Study Completion: October 4, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data sharing will generally coincide with publication of the study's main findings no later than 1 year after acceptance of the primary manuscript or study closure, whichever comes first.
• Access Criteria: To access data in the DASH repository, users will be required to register in DASH, belong to an institution with an approved assurance from the Department of Health and Human Services Office for Human Research Protections, submit a research plan, execute a DASH data use agreement, submit approval from their local IRB, obtain approval by the DASH Data Access Committee, and obtain approval from the Study-Specific Approving Entity. To access data through the PATC3H consortium, researchers must be on one of the PATC3H consortium research teams; the decision to share data will be at the discretion of the principal investigator.

Locations

ZA (1)