PrEP rapid adherence feedback improves PrEP use in postpartum women

HIV incidence remains unacceptably high in pregnant and breastfeeding women, contributing to persistent high levels of infant HIV acquisition in South Africa. Being able to offer pregnant and postpartum women who are at risk of HIV daily oral pre-exposure prophylaxis is an important step in eliminating vertical HIV transmission.

In a busy urban clinic in Cape Town, South Africa, we have integrated PrEP counselling and offer PrEP to all HIV-negative pregnant and breastfeeding women (16+ years of age) who are interested and eligible. However, we found steep declines in PrEP use in the postpartum period, when women were no longer returning for regular antenatal care. Following in-depth interviews with pregnant women who reported high levels of adherence to daily PrEP but had no or low levels of tenofovir in their blood, we hypothesized that real-time adherence monitoring and biofeedback may improve PrEP adherence. Further, over a third of women reported they did not know their partner’s serostatus. So we integrated HIV self-testing (OraQuick oral HIV tests) to evaluate acceptability of this testing for partners and PrEP-using women.

We recently published a study describing our work in Open Forum Infectious Diseases, and our key findings are outlined below:

• We randomized 106 postpartum women (median age 26 years) who were on PrEP while pregnant to the intervention group (HIV self-testing + biofeedback counselling following urine tenofovir test) or to standard of care (facility-based HIV tests and routine counselling without biofeedback) to evaluate PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1 month after randomization.
• At enrolment most women reported good, recent PrEP adherence with 72% of women reporting missing <2 doses in the past week. However, only 36% of women had tenofovir present in their urine. One month after enrolment, the proportion of women with tenofovir in their urine almost doubled in the intervention group (62%) compared to 34% in the control group (relative risk, 1.83; 95% confidence interval, 1.19-2.82).
• For secondary distribution of the HIV self-tests, 66% of women in the intervention arm reported that their partner tested for HIV in the past month (with a picture or returned test for confirmation) compared to 17% in the control group (relative risk, 3.89; 95% confidence interval, 2.08-7.27).
• Acceptability of the biofeedback in women using PrEP combined with HIV self-testing was high. All women said that they understood the results, and 98% said they would like to get the test again in the future. However, five women stated that the result was not as they expected, all of whom had received a negative tenofovir urine test result, indicative of missing PrEP in the past 48-72 hours, although they had reported taking PrEP in the last week (and therefore had expected a tenofovir+ result).
• No social or clinical adverse events were reported in the intervention arm.
• Study counsellors found that reframing discussions from daily PrEP “adherence” to the “protection” perspective (and condom use if having sex whilst not using PrEP daily) encouraged adherence among consistent PrEP users, while not being punitive or judgemental about intermittent or non-use of PrEP.

Our study is the first of its kind to evaluate a combination intervention with HIV self-testing for PrEP users and their partners plus adherence biofeedback counselling using urine tenofovir testing to improve recent PrEP adherence in postpartum women. Adherence was almost double that of the standard of care in postpartum women on PrEP, and partner testing occurred four times as frequently in the intervention compared to the control group. These preliminary results suggest that simple combination interventions may be highly effective in improving PrEP adherence in this population. More research is needed to understand the mechanisms of action, scalability and longer-term effect of the intervention.