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Daily Vaginal Swabs and Mobile Phone Sex Report for Assessing HIV Virion Exposure Prospectively Among a Cohort of Young Sexually Active Women in South Africa (HVTN 915)

Lemos, Maria P., PhDa; Lazarus, Erica, MBChBb; Isaacs, Abby, MSca; Dietrich, Janan, PhDb; Morgan, Cecilia, PhDa; Huang, Yunda, PhDa; Grove, Doug, MSca; Andrasik, Michele, PhDa; Laher, Fatima, MBBChb; Hural, John, PhDa; Chung, Eva, PhDa; Dragavon, Joan, MLMc; Puren, Adrian, MBBChd; Gulati, Reena K., MDa; Coombs, Robert, MDc,e; McElrath, Margaret Juliana, MDa,c,e,f; Gray, Glenda, MBBChb,g; Kublin, James G., MDa

JAIDS Journal of Acquired Immune Deficiency Syndromes: June 1, 2019 - Volume 81 - Issue 2 - p e39–e48
doi: 10.1097/QAI.0000000000002015
Prevention Research
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Background: Measurements of HIV exposure could help identify subpopulations at highest risk of acquisition and improve the design of HIV prevention efficacy trials and public health interventions. The HVTN 915 study evaluated the feasibility of self-administered vaginal swabs for detection of HIV virions to assess exposure.

Methods: Fifty 18- to 25-year-old sexually active HIV-seronegative women using contraception were enrolled in Soweto, South Africa. Participants self-administered daily vaginal swabs and answered sexual behavior questions through mobile phone for 90 days. Clinician-administered vaginal swabs, behavioral questionnaires, HIV diagnostic testing, and counseling were performed at 8 clinic visits. Glycogen concentrations assessed adherence to swabbing. Y-chromosome DNA (Yc-DNA) assessed the accuracy of reported condom use. HIV exposure was measured by virion polymerase chain reaction in swabs from 41 women who reported unprotected vaginal sex during follow-up.

Results: Glycogen was detected in 315/336 (93.8%) participant-collected and in all clinician-collected swabs. Approximately 20/39 daily swabs (51.3%) linked to mobile reports of unprotected sex tested positive for Yc-DNA, whereas 10/187 swabs collected after 3 days of abstinence or protected sex (5.3%) had detectable Yc-DNA. No participant became HIV infected during the study; yet, exposure to HIV was detected by nucleic acids in 2 vaginal swabs from 1 participant, collected less than 1 hour after coitus.

Conclusion: There was high adherence to daily vaginal swabbing. Daily mobile surveys had accurate reporting of unprotected sex. Detection of HIV in self-collected vaginal swabs from an uninfected participant demonstrated it was possible to measure HIV exposure, but the detection rate was lower than expected.

aVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

bPerinatal HIV Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa;

cDepartment of Laboratory Medicine, University of Washington, Seattle, WA;

dCentre of HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases, Johannesburg, South Africa;

Departments of eMedicine;

fGlobal Health, University of Washington, Seattle, WA; and

gSouth African Medical Research Council, Cape Town, South Africa.

Correspondence to: James G. Kublin, MD, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA (e-mail: jkublin@fredhutch.org).

Supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health US Public Health Service Grants UM1AI068614 [HVTN LOC], UM1AI068635 [HVTN SDMC], UM1AI068618 [HVTN Laboratory Center], UM1AI069453 [Soweto-Bara CRS], UW CFAR P30AI027757 [UW, Virology Laboratory], and UM1AI106701 [ACTG Laboratory Center]. Dr. Dietrich received a Thuthuka award from the South African National Research Foundation (SA-NRF) and an HIV Initiatives Program Award. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or SA-NRF.

Presented at “High Adherence to Daily Vaginal Swabs and Reliable Sexual Behavior Reporting via Mobile Phone App for Assessing HIV Virion Exposure (HVTN 915)” R4P Research for Prevention; October 18, 2016; Chicago, IL.

The authors have no funding or conflicts of interest to disclose.

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Received October 17, 2018

Accepted January 28, 2019

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