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

HIV Infections Clinical Trial

— IMARA-SA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04758390
• Other study ID #: 2018-0709
• Secondary ID: UH3HD096875
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 525 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1290
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• IMARA (intervention group)
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.
• 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.

Locations

Country	Name	City	State
South Africa	Desmond Tutu Health Foundation	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Desmond Tutu Health Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

South Africa, 

References & Publications (7)

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.

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. — View 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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of female caregivers (FC) with an STI at baseline, midline, and endline	A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Other	Proportion of FC who complete HTC at baseline, midline, and endline	Completion of HTC	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Other	Proportion of FC who elect to take PrEP baseline, midline, and endline	Uptake of PrEP	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Other	Proportion of FC who report risky sexual behavior at baseline, midline, and endline	Sexual behavior (e.g., condom use, substance use during sex, number of partners, concurrent partners) will be measured via self-report using the AIDS Risk Behavior Assessment (ARBA) (Donenberg, 2001)	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Other	Proportion of FC who test positive for HIV at baseline, midline, and endline	A positive test for HIV during HTC	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Other	Intervention feasibility	Feasibility will be measured through surveys completed by participants and study staff using items adapted from the Johns Hopkins' Applied Mental Health Research (AMHR) implementation science measure (Haroz et al, 2019).	The study duration (~2.5 years)
Other	Intervention acceptability	Acceptability will be measured through surveys completed by participants and study staff using items adapted from the Johns Hopkins' AMHR implementation science measure (Haroz et al, 2019).	The study duration (~2.5 years)
Other	Intervention appropriateness	Appropriateness will be measured through surveys completed by participants and study staff using items adapted from the Johns Hopkins' AMHR implementation science measure (Haroz et al, 2019).	The study duration (~2.5 years)
Other	Intervention reach	Reach will be assessed through surveys completed by participants and study staff using items adapted from the Johns Hopkins' AMHR implementation science measure (Haroz et al, 2019).	The study duration (~2.5 years)
Other	Intervention adoption	Adoption will be assessed through surveys completed by participants and study staff using items adapted from the Antiretroviral Treatment Access Study (ARTAS) (Norton et al, 2012).	The study duration (~2.5 years)
Other	Intervention fidelity	Fidelity will be assessed by facilitators and observers of the intervention using an adapted version of the Treatment Fidelity Questionnaire (Lane et al, 2004).	The study duration (~2.5 years)
Primary	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)
Primary	Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and midline	Completion of HTC	~6 months (from baseline to midline)
Primary	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	Proportion of AGYW with an STI at baseline and endline	A positive test for at least one of three STIs: chlamydia, gonorrhea, and/or trichomoniasis	~12 months (from baseline to endline)
Secondary	Proportion of AGYW who complete HTC at baseline and endline	Completion of HTC	~12 months (from baseline to endline)
Secondary	Proportion of AGYW who elect to take PrEP at baseline and endline	Uptake of PrEP	~12 months (from baseline to endline)
Secondary	Proportion of AGYW who report risky sexual behavior at baseline, midline, and endline	Sexual behavior (e.g., condom use, substance use during sex, number of partners, concurrent partners) will be measured via self-report using the AIDS Risk Behavior Assessment (ARBA) (Donenberg, 2001).	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Secondary	Proportion of AGYW who report adherence to PrEP at baseline, midline, and endline	Adherence to PrEP (where appropriate) will be measured via self-report using items from the Wilson scale (2017)	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Secondary	Proportion of AGYW who report adherence to antiretroviral therapy (ART) at baseline, midline, and endline	Adherence to ART (where appropriate) will be measured via self-report using items from the Wilson scale (2017)	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Secondary	Proportion of AGYW who test positive for HIV at baseline, midline, and endline	A positive test for HIV during HTC	~6 months (from baseline to midline) and ~12 months (from baseline to endline)
Secondary	Intervention cost-effectiveness	The cost-effectiveness ratio, defined as the incremental cost of the IMARA intervention per infection prevented by the intervention.	The study duration (~2.5 years)