Clinical trial NCT04758390: A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Official title: Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
HIV Infections
Keywords: HIV prevention
Adolescent girls and young women
South Africa
Mother-daughter intervention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Desmond Tutu Health Foundation
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-02-17
Enrollment: 1290
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA intervention arm or a health promotion control arm matched in time and intensity. IMARA and the health promotion program will be delivered as group interventions.
Primary purpose: PREVENTION

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.

Detailed description: Reducing new HIV and STI infections among South African (SA) adolescent girls and young women (AGYW) is global public health priority. SA has the world's largest HIV epidemic, and SA AGYW acquire HIV at twice the rate of and seroconvert on average 5 - 7 years earlier than male peers. As new infections continue to outpace access to and availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), primary prevention remains the most viable strategy to stem new transmission. SA efforts to prevent HIV transmission in youth focus mostly on individual-level behavior change, but AGYW's persistent HIV disparities are explained by broad social and structural inequities that shape and constrain HIV-risk behaviors. Comprehensive HIV prevention packages that are integrated, synergistic, and tailored to the local epidemiology and cultural context are likely to achieve and sustain maximum reductions in HIV-risk. Female caregivers (FC) are an untapped resource in the HIV prevention toolbox and offer a novel opportunity to strengthen AGYW prevention efforts. AGYW may also be change agents for their FC who want to be positive role models for AGYW, and thus, adopt HIV prevention behaviors, including HTC and PrEP.

This study will evaluate the effectiveness and cost-effectiveness of Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), a multilevel, innovative, family-based HIV prevention program that targets individual, social, and structural drivers of risk. IMARA demonstrated a 43% reduction in incident STI at 12-month follow-up among black 14-18-year-old girls in the US. IMARA has been systematically tailored for the SA context and piloted among AGYW and FC dyads. A two-arm RCT will now be conducted with about 645 AGYW (15-19 years old) and FC dyads. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (\~12 hours) that includes joint and separate mother and daughter activities. AGYW and FC will complete baseline, 6-, and 12-month assessments, including testing for three STI (chlamydia, gonorrhea, and trichomoniasis). We will offer HTC and PrEP at each assessment and track uptake and linkage to care. AGYW and FC who are HIV-negative and interested in PrEP will receive a one-month supply and referral to a clinic. They will additionally receive treatment and counseling if testing positive for an STI and referral for care at an ART clinic if testing positive for HIV. Data will be collected to determine the costs of IMARA. Analyses will compare AGYW across the intervention and control programs on STI incidence, and PrEP and HTC uptake, in addition to secondary outcomes. We will also evaluate the costs and cost-effectiveness of IMARA with respect to the acquisition of STI and HIV, where possible considering power limitations. Additionally, the intervention's implementation will be explored. The study answers an urgent need to evaluate the effectiveness and cost-effectiveness of combination HIV prevention packages for AGYW.

Eligibility criteria: Inclusion criteria for AGYW include:

* female;
* 15-19 years-old;
* residing in Klipfontein/Mitchells Plain (K/MP);
* speak isiXhosa or English or a combination of these languages;
* willing to have biometric data collected.

Inclusion criteria for FC include:

* identified by AGYW as a FC;
* 24 years and older;
* living with or in daily contact with the AGYW;
* speak isiXhosa or English or a combination of these languages;
* willing to have biometric data collected.

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 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.

Primary outcomes:
measure: Proportion of adolescent girls and young women (AGYW) with a sexually-transmitted infection (STI) at baseline and midline
timeFrame: ~6 months (from baseline to midline)
measure: Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and midline
timeFrame: ~6 months (from baseline to midline)
measure: Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and midline
timeFrame: ~6 months (from baseline to midline)
Secondary outcomes:
measure: Proportion of AGYW with an STI at baseline and endline
timeFrame: ~12 months (from baseline to endline)
measure: Proportion of AGYW who complete HTC at baseline and endline
timeFrame: ~12 months (from baseline to endline)
measure: Proportion of AGYW who elect to take PrEP at baseline and endline
timeFrame: ~12 months (from baseline to endline)
measure: Proportion of AGYW who report risky sexual behavior at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of AGYW who report adherence to PrEP at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of AGYW who report adherence to antiretroviral therapy (ART) at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of AGYW who test positive for HIV at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Intervention cost-effectiveness
timeFrame: The study duration (~2.5 years)
Other outcomes:
measure: Proportion of female caregivers (FC) with an STI at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of FC who complete HTC at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of FC who elect to take PrEP baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of FC who report risky sexual behavior at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Proportion of FC who test positive for HIV at baseline, midline, and endline
timeFrame: ~6 months (from baseline to midline) and ~12 months (from baseline to endline)
measure: Intervention feasibility
timeFrame: The study duration (~2.5 years)
measure: Intervention acceptability
timeFrame: The study duration (~2.5 years)
measure: Intervention appropriateness
timeFrame: The study duration (~2.5 years)
measure: Intervention reach
timeFrame: The study duration (~2.5 years)
measure: Intervention adoption
timeFrame: The study duration (~2.5 years)
measure: Intervention fidelity
timeFrame: The study duration (~2.5 years)
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
Study officials:
affiliation: University of Illinois at Chicago
name: Geri R Donenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmond Tutu Health Foundation
name: Linda-Gail Bekker, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.