Pre-exposure Prophylaxis Recent Adherence With Real-Time Adherence Feedback and Partner Human Immunodeficiency Virus Self-Testing: A Pilot Trial Among Postpartum Women

Dvora Leah Joseph Davey, Kathryn Dovel, Rufaro Mvududu, Dorothy Nyemba, Nyiko Mashele, Linda-Gail Bekker, Pamina M Gorbach, Thomas J Coates, Landon Myer, Dvora Leah Joseph Davey, Kathryn Dovel, Rufaro Mvududu, Dorothy Nyemba, Nyiko Mashele, Linda-Gail Bekker, Pamina M Gorbach, Thomas J Coates, Landon Myer

Abstract

Background: Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. Human immunodeficiency virus self-testing (HIVST) for male partners combined with biofeedback counseling through real-time adherence measures may improve PrEP use among postpartum women.

Methods: Between August 2020 and April 2021, we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counseling after urine tenofovir test) or to standard of care ([SOC] facility-based human immunodeficiency virus [HIV] tests and routine counseling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomization. Secondary outcomes included the proportion of partners who tested for HIV and the discrepancy between self-reported PrEP adherence and urine tenofovir result.

Results: We enrolled 106 women (median age = 26 years). At enrollment, 72% of women reported missing <2 doses in the past 7 days; 36% of women had tenofovir present in her urine. One month after enrollment, 62% (n = 33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n = 18) in SOC (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.19-2.82; P = .001). Two thirds of women in the intervention arm reported that her partner tested for HIV (66%; n = 35), compared to 17% (n = 9) in SOC (RR = 3.89; 95% CI = 2.08-7.27; P < .001). Self-reported PrEP adherence (took PrEP >5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR = 0.33; 95% CI = 0.17-0.67; P = .03). No social or clinical adverse events were reported in the intervention arm.

Conclusions: The HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population.

Keywords: South Africa; adherence; breastfeeding; pre-exposure prophylaxis; pregnant.

© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Consort diagram. Participant flow of women screened, enrolled, and randomized in the postpartum adherence study, Cape Town, South Africa, August 2020–April 2021. HIV, human immunodeficiency virus.
Figure 2.
Figure 2.
Results from randomized control trail of male partner human immunodeficiency virus (HIV) testing and urine tenofovir (TFV) testing with self-reported pre-exposure prophylaxis (PrEP) adherence results postpartum women (N = 106) in Cape Town, South Africa, August 2020–April 2021. RD, risk difference; RR, risk ratio; SOC, standard of care.

References

    1. Graybill LA, Kasaro M, Freeborn K, et al. . Incident HIV among pregnant and breast-feeding women in sub-Saharan Africa: a systematic review and meta-analysis. AIDS 2020; 34:761–76.
    1. Thomson KA, Hughes J, Baeten JM, et al. . Increased risk of HIV acquisition among women throughout pregnancy and during the postpartum period: a prospective per-coital-act analysis among women with HIV-infected partners. J Infect Dis 2018; 218:16–25.
    1. Joseph Davey DL, Nyemba DC, Gomba Y, et al. . Prevalence and correlates of sexually transmitted infections in pregnancy in HIV-infected and- uninfected women in Cape Town, South Africa. PLoS One 2019; 14:e0218349.
    1. Joseph Davey D, Farley E, Gomba Y, et al. . Sexual risk during pregnancy and postpartum periods among HIV-infected and -uninfected South African women: implications for primary and secondary HIV prevention interventions. PLoS One 2018; 13:e0192982.
    1. Van de Perre P, Goga A, Ngandu N, et al. . Eliminating postnatal HIV transmission in high incidence areas: need for complementary biomedical interventions. Lancet 2021; 397:1316–24.
    1. Velloza J, Khoza N, Scorgie F, et al. . The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study. J Int AIDS Soc 2020; 23:e25463.
    1. Scorgie F, Khoza N, Baron D, et al. . Disclosure of PrEP use by young women in South Africa and Tanzania: qualitative findings from a demonstration project. Cult Health Sex 2021; 23:257–72.
    1. Janes H, Corey L, Ramjee G, et al. . Weighing the evidence of efficacy of oral PrEP for HIV prevention in women in Southern Africa. AIDS Res Hum Retroviruses 2018; 34:645–56.
    1. Thomson KA, Baeten JM, Mugo NR, et al. . Tenofovir-based oral preexposure prophylaxis prevents HIV infection among women. Curr Opin HIV AIDS 2016; 11:18–26.
    1. Corneli A, Perry B, McKenna K, et al. . Participants’ explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr 2016; 71:452–61.
    1. Kinuthia J, Pintye J, Abuna F, et al. . Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme. Lancet HIV 2020; 7:e38–48.
    1. Joseph Davey DL, Mvududu R, Mashele N, et al. . Early pre-exposure prophylaxis (PrEP) discontinuation among pregnant and postpartum women: implications for maternal PrEP roll out in South Africa [preprint]. medRxiv 2021.
    1. Joseph Davey DL, Bekker LG, Gorbach PM, et al. . Delivering preexposure prophylaxis to pregnant and breastfeeding women in sub-Saharan Africa: the implementation science frontier. AIDS 2017; 31:2193–7.
    1. Pintye J, Davey DLJ, Wagner AD, et al. . Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework. Lancet HIV 2020; 7:e582–92.
    1. Joseph Davey DL, Pintye J, Baeten JM, et al. . Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading? J Int AIDS Soc 2020; 23:e25426.
    1. Joseph Davey DL, Knight L, Markt-Maloney J, et al. . "I had made the decision, and no one was going to stop me"—facilitators of PrEP adherence during pregnancy and postpartum in Cape Town, South Africa. AIDS Behav 2021; 25:3978–86.
    1. Agot K, Taylor D, Corneli AL, et al. . Accuracy of self-report and pill-count measures of adherence in the FEM-PrEP clinical trial: implications for future HIV-prevention trials. AIDS Behav 2015; 19:743–51.
    1. Montgomery ET, Mensch B, Musara P, et al. . Misreporting of product adherence in the MTN-003/VOICE trial for HIV prevention in Africa: participants’ explanations for dishonesty. AIDS Behav 2017; 21:481–91.
    1. van der Straten A, Stadler J, Luecke E, et al. . Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: the VOICE-C qualitative study in Johannesburg, South Africa. J Int AIDS Soc 2014; 17(3 Suppl 2):19146.
    1. Amico KR, Wallace M, Bekker LG, et al. . Experiences with HPTN 067/ADAPT study-provided open-label PrEP among women in Cape Town: facilitators and barriers within a mutuality framework. AIDS Behav 2017; 21:1361–75.
    1. Hebel S, Kahn-Woods E, Malone-Thomas S, et al. . Discrepancies between self-reported adherence and a biomarker of adherence in real-world settings. J Acquir Immune Defic Syndr 2020; 85:454–7.
    1. Drain P, Ngure K, Mugo N, et al. . Testing a real-time tenofovir urine adherence assay for monitoring and providing feedback to preexposure prophylaxis in Kenya (PUMA): protocol for a pilot randomized controlled trial. JMIR Res Protoc 2020; 9:e15029.
    1. Landovitz RJ, Beymer M, Kofron R, et al. . Plasma tenofovir levels to support adherence to TDF/FTC preexposure prophylaxis for HIV prevention in MSM in Los Angeles, California. J Acquir Immune Defic Syndr 2017; 76:501–11.
    1. Koester KA, Liu A, Eden C, et al. . Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study. AIDS Care 2015; 27:1199–204.
    1. van der Straten A, Montgomery ET, Musara P, et al. . Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS 2015; 29:2161–71.
    1. Corneli A, Perry B, Agot K, et al. . Facilitators of adherence to the study pill in the FEM-PrEP clinical trial. PLoS One 2015; 10:e0125458.
    1. Spinelli MA, Rodrigues WC, Wang G, et al. . Brief report: high accuracy of a real-time urine antibody-based tenofovir point-of-care test compared with laboratory-based ELISA in diverse populations. J Acquir Immune Defic Syndr 2020; 84:149–52.
    1. Gandhi M, Wang G, King R, et al. . Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS 2020; 34:255–60.
    1. Daughtridge G. Development and validation of a point-of-care, urine assay to measure adherence to PrEP and ART. IAS Conference on HIV Science (Mexico City, Mexico). July 14–21, 2019.
    1. Department of Health South Africa. National HIV counselling and testing policy guidelines. Available at: . Accessed 9 June 2017.
    1. Ickovics JR, Meisler AW.. Adherence in AIDS clinical trials: a framework for clinical research and clinical care. J Clin Epidemiol 1997; 50:385–91.
    1. Bernstein M, Phillips T, Zerbe A, et al. . Intimate partner violence experienced by HIV-infected pregnant women in South Africa: a cross-sectional study. BMJ Open 2016; 6:e011999.
    1. Moran A, Mashele N, Mvududu R, et al. . Maternal PrEP Use in HIV-uninfected pregnant women in South Africa: role of stigma in PrEP initiation, retention and adherence. AIDS Behav 2021:1–13.
    1. Oyaro P, Kwena Z, Bukusi EA, Baeten JM.. Is HIV self-testing a strategy to increase repeat testing among pregnant and postpartum women? A pilot mixed methods study. J Acquir Immune Defic Syndr 2020; 84:365–71.
    1. Balán IC, Giguere R, Lentz C, et al. . Client-centered adherence counseling with adherence measurement feedback to support use of the dapivirine ring in MTN-025 (The HOPE Study). AIDS Behav 2021; 25:447–58.
    1. Celum CL, Gill K, Morton JF, et al. . Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial. J Int AIDS Soc 2020; 23:e25636.
    1. Alexander Moran LM, Mashele N, Coates T, et al. . Maternal PrEP use in HIV-uninfected pregnant women in South Africa: role of Stigma in PrEP initiation and persistence. International Workshop on HIV Pediatrics (Virtual). August 2020.
    1. Joseph Davey D. Partners support, disclosure and side effects: facilitators of high maternal PrEP adherence in Cape Town, South Africa. HIVR4P (Virtual). January 2021.
    1. Thirumurthy H, Masters SH, Mavedzenge SN, et al. . Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV 2016; 3:e266–74.
    1. Masters SH, Agot K, Obonyo B, et al. . Promoting partner testing and couples testing through secondary distribution of HIV self-tests: a randomized clinical trial. PLoS Med 2016; 13:e1002166.
    1. Choko AT, Corbett EL, Stallard N, et al. . HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: an adaptive multi-arm, multi-stage cluster randomised trial. PLoS Med 2019; 16:e1002719.
    1. Gichangi A, Wambua J, Mutwiwa S, et al. . Impact of HIV self-test distribution to male partners of ANC clients: results of a randomized controlled trial in Kenya. J Acquir Immune Defic Syndr 2018; 79:467–73.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj