The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study
Launched by JOHNS HOPKINS UNIVERSITY · Dec 16, 2024
Trial Information
Current as of July 04, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The IN-STEP Study is a clinical trial aimed at improving ways to prevent HIV infection among women in eastern and southern Africa, where new HIV cases are rising, particularly among women in relationships with high-risk male partners. The study will compare two approaches for identifying women who may benefit from pre-exposure prophylaxis (PrEP), a medication that helps prevent HIV. One group will receive PrEP screening based on standard questions about risk factors, while the other group will also undergo testing for common sexually transmitted infections (STIs) like chlamydia and gonorrhea. The researchers believe that testing for these infections will help find more women at risk for HIV and encourage them to use PrEP.
Women between the ages of 15 and 39 who are sexually active and live in specific communities in Uganda are eligible to participate. This includes pregnant women. Participants will be randomly assigned to one of the two screening methods and will have access to standard care for STIs. Throughout the study, researchers will track how many women start and continue using PrEP, and they will also gather feedback to understand what helps or hinders their use of the medication. The findings from this research could lead to better strategies for HIV prevention in Africa by combining STI testing with HIV prevention programs.
Gender
FEMALE
Eligibility criteria
- Inclusion criteria:
- • Sexually active females aged 15-39 years,
- • resident in Rakai Community Cohort Study (RCCS) communities and who have participated in the most recent RCCS survey will be eligible to participate irrespective of their HIV serostatus.
- • Pregnant women will be included in this study
- • Additionally, eligibility criteria include participation in the most recent RCCS with consent to store and test plasma specimens collected during the RCCS visit,
- • consent to be re-contacted for future studies, and
- • willingness to be randomized in IN-STEP.
- Exclusion criteria:
- • Individuals incapable of providing consent or
- • not meeting the above criteria will be excluded from the study.
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kalisizo, , Uganda
Patients applied
Trial Officials
Mary Kathryn Grabowski, Associate Professor, PhD
Principal Investigator
Johns Hopkins School of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported