Pre-exposure prophylaxis adherence with real-time adherence feedback and partner HIV self-testing: A pilot trial among postpartum women

Background: Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. HIV self-testing (HIVST) for partners combined with biofeedback counselling through real-time adherence measures may improve daily PrEP use among postpartum women. Methods: Between August 2020 and April 2021 we conducted a pilot study in one primary care clinic in Cape Town, South Africa. We randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counselling following urine tenofovir test) or to standard of care (facility-based HIV tests and routine counselling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomisation. Secondary outcomes included proportion of partners who tested for HIV and discrepancy between self-reported PrEP adherence and urine tenofovir result. Results: We enrolled 106 women (median age=26 years; median months postpartum=2). Almost half of women reported having sex since giving birth (48%); 76% of those reported condomless sex at last sex. At enrolment most women (72%) reported missing <2 doses in the past 7-days; 36% of women had tenofovir present in her urine (no significant differences by arm). One month after enrolment, 62% (n=33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n=18) in the standard of care arm (RR=1.83; 95% CI=1.19, 2.82). Two-thirds of women in the intervention arm reported that her partner tested for HIV (66%; n=35); compared to 17% (n=9) in the standard of care arm (RR=3.89; 95% CI=2.08, 7.27). The proportion of women with a discrepant adherence result (self-reported good recent adherence with no tenofovir in urine test) was significantly lower in the intervention group (n=8; 17%) compared to the standard of care group (n=24; 46%) (RR=0.33; 95% CI=0.17, 0.67). No social or clinical adverse events were reported in the intervention arm. Conclusions: In this pilot study, 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.