Increased risk of STI and HIV among adolescent girls and young women due to COVID-19 and pandemic mitigation: Biological, behavioral, and psychosocial mediators

The CACHE 2 STUDY

Start:                     January 2022

Status:                  Follow ups ongoing

Design:                 Clinical Trial

Study Sites:        UNIM Research and Training Centre

Sponsor:              National Institutes of Health  

IRB:                        Maseno University Ethical Review Committee MUERC/01021/22

Purpose:              The overall goal is to measure the socioeconomic and behavioral impacts of COVID-19, and how these relate to girls’ subsequent risk of HIV, STI, and pregnancy.

Design:                 This study will conduct 6-monthly study visits to girls at school or in the community if schools are closed, or if they have left or dropped out to implement survey procedures, using the same methods and approaches used in the prior trial and sub-study. This comprises the self-completed sociodemographic and behavioral survey on Android tablets (using Open Data Kit software) with research assistants on hand to assist as needed, a blood draw for HIV testing, measurement of anthropometric measures (height, weight, waist, hips), and self-collected vaginal swabs for BV and STI testing and vaginal microbiome (VMB) measurement. At each visit, following a standardized script, study staff will provide definitions of sexual behavior, assurances of confidentiality and emphasize that answers will not be shared with parents or school staff, and information will be provided about symptoms and signs of STIs and BV, and how to protect against these infections. For the girls in the menstrual cup arm, the study staff will also repeat use and safety training on menstrual cup use. Evaluations and data collection will occur at 0 and at five follow-up visits at 6, 12, 18, 24, and 30 months.

Population:        AGYW participant previously enrolled in the prior CaCHe vaginal microbiome sub-study, consenting to participate in this follow-up study with other participants (e.g. parents, teachers, community stakeholders) living and/or working in study area and consenting to participate

Study Size:          The CaCHe participants included 436 adolescent girls and young women (AGYW) who were aged 14-25 years at enrollment into one of 6 schools; 3 schools where participating girls were provided with menstrual cups, and 3 schools where girls were allocated under the control arm.

Study Aims:        Aim 1: Quantify the economic, social, and behavioral impacts of COVID-19 and associated lockdowns and restrictions.

Aim 2: Measure association of COVID-19 stressors on long-term risk for HIV and STIs.

Aim 3: Determine the extent to which risk of BV, and STI/HIV is biologically mediated by stress.

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