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Implementing a rapid response to the COVID-19 global pandemic in MTN-034/REACH: an HIV prevention trial among adolescent girls and young women in Africa

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BACKGROUND: The MTN-034/REACH trial, evaluating safety and preferences of oral pre-exposure prophylaxis (PrEP) and the dapivirine vaginal ring among adolescent girls and young women (AGYW) in sub-Saharan Africa, was in full implementation when the COVID-19 pandemic erupted. Associated socio-economic upheaval and mobility disruptions impacted the 247 enrolled AGYW, and staff, potentially jeopardizing study quality and development of HIV prevention methods. In response, accrual was paused and rapid modifications to follow-up procedures were implemented to distribute study product, monitor safety, handle biological samples and testing, and support product adherence.
METHODS: As sites prepared for impending lockdowns, guidance was issued regarding safety and confidentiality precautions, mitigating social harms (e.g. counseling/referrals, reimbursements for food security) and COVID-19 education for participants and staff. A contingency plan for study conduct, tiered by operational status, was developed and implemented according to site capacity. All modifications, including telephonic visits in lieu of clinic visits, providing extra study product, and prioritizing in-person procedures, were monitored in real-time for operational and analysis considerations. Community engagement included study updates to local stakeholders and delivery of COVID-19 key messages for community sensitization.
RESULTS: Implementation modifications during country lockdowns resulted in nearly uninterrupted study product and contraceptive access for participants. Clinic access remained critical for participants without options for secure telephonic visits or with onsite needs, therefore sites operated in reduced capacity, with staff rotations and transport for staff and participants. Counselors expanded adherence support with remote reminders and check-ins, using alternative documentation and confidentiality practices. Completion rates for expected study visits and procedures were high. Sites maintained contact with most participants despite lockdowns (Table 1).

Expected visits and procedures completed during operational disruptionsCompleted/expected (%) from 26MAR-29APR2020
Expected Visits Completed*172/200 (86)
Expected in-clinic visits completed as telephonic**111/200 (55)
Expected clinic/testing procedures completed***
- Physical Exam141/144 (97.9)
- Pelvic Exams completed44/45 (97.8)
- Pregnancy test138/144 (97.2)
- HIV-1 testing138/14 (97.2)
*Visits completed within protocol-defined window, including telephonic contacts with modified procedures in lieu of in-clinic visits.
**Includes visits partially done telephonically
***Expected key clinical/testing procedures completed for visits conducted. Missed procedures due to modified visits (e.g. telephonic, shortened in-clinic visit).










CONCLUSIONS: Well-orchestrated modifications to study implementation ensured participant and staff safety, and maintained study integrity and community engagement during COVID-related disruptions. The MTN-034/REACH strategy serves as a template for optimal study operations during times of upheaval, especially when supporting AGYW.