HIVST acceptance and PrEP initiation among pregnant women at high risk of HIV in Homa Bay and Siaya counties, Kenya

Thesis (Master's)--University of Washington, 2021Background: Sub-Saharan Africa has the highest incidence of HIV worldwide with women having a higher incidence than men. Pregnancy increases risk for HIV acquisition which can increase the risk of vertical HIV transmission. Low rates of HIV testing in male partners is an important driver of incident HIV infection among pregnant women. Distribution of HIV self-tests (HIVST) for male partners can facilitate male partner HIV testing and help women make informed decisions about PrEP. This study aims to understand how acceptance of HIVST for male partner testing influences PrEP acceptance among pregnant women, identify cofactors of HIVST, PrEP, and of combined HIVST and PrEP, and influence of HIVST on knowledge of partner HIV status. Methods: This study utilized longitudinal data from the targeted arm of the PrEP Implementation of Mothers in Antenatal care study, a cluster-randomized clinical trial evaluating two models of PrEP delivery in pregnant women conducted in Homa Bay and Siaya counties. Within the targeted arm, pregnant women were assessed using an objective HIV risk assessment tool. Women at high risk of HIV acquisition were systematically offered PrEP and were included in this analysis. Additionally, women in this arm were offered HIVST for their male partners and were asked to report on the HIVST results of their partners at their next visit. Data including HIVST acceptance, PrEP acceptance, PrEP discontinuation, male partner HIVST acceptance and HIVST reported by the participants was captured. Presence of intimate partner violence (IPV) was assessed using the Hurt-Insult-Threaten-Scream (HITS) screening tool. Depression was assessed using the Patient Health Questionnaire-2 (PHQ2) while social support was evaluated using the 18-item Medical Outcomes Study Social Support Survey (MOS-SSS). Chi-squared tests were utilized to compare the association between HIVST acceptance for male partner and PrEP acceptance. Univariate logistic regression was used to compare participant demographics, pregnancy characteristics and male partner characteristics between women who accepted either intervention or accepted both interventions compared to those who declined both HIVST and PrEP (reference group). Results: Of 2,197 women in the targeted arm, 1,008 (46%) women were determine to be at high risk of HIV acquisition and were included in the analysis. Median age of women was 25 years and 88.4% were married. Approximately 46.7% perceived themselves to be at high risk of HIV acquisition, 51.1% reported high social support, 12.8% reported experiencing IPV and 16.9% reported signs of depression. Male partners had a median age of 31 years, with 16.4% being >10 years older. Overall, 86.1% of women reported that they did not know their partner’s HIV status. Of 1,008 high-risk pregnant women, 50% accepted HIVST only, 13.9% accepted both HIVST and PrEP and 10.2% accepted PrEP only. Overall, 63.9% accepted HIVST, of whom 80.9% offered them to their male partners; 69.1% used the HIVST kits and 67.2% of the women tested together with their male partners. Overall, 68.7% of women became newly aware of their partners HIV status by 9 months postpartum with 1.9% of these partners having a positive HIVST. Cofactors for accepting either PrEP or HIVST included HIV risk perception, social support, parity, male partner HIV status and marital status/type of partnership. Cofactors for accepting PrEP alone included the woman’s age, the male partner’s age and presence of IPV. Cofactors for accepting HIVST alone included the woman’s level of education. Cofactors for accepting both HIVST and PrEP included social support, presence of IPV, depression and suspicion of male partners’ having other sexual partners. Unawareness of male partner HIV status and high HIV risk perception were the facilitators of uptake of PrEP. The major barrier of accepting both HIVST and PrEP was need to consult the male partner. Other barriers of accepting PrEP included their need for more time to think, pill burden and low HIV risk perception Conclusion: Distribution of HIVST for male partner testing was acceptable and useful to help high risk pregnant women navigate decisions about PrEP. Understanding the factors that foster high risk pregnant women to accept HIVST only, PrEP only or accept both HIVST and PrEP is key in informing and scaling up HIVST programming and PrEP counselling for pregnant women

Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis

Abstract Background There is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization. Methods The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders’ perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process. Results Among 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders’ decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients. Conclusions The most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes

Risk‐based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019

Abstract Introduction Integrating pre‐exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk‐guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP. Methods The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self‐selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk‐scoring tool and an offer of HIV self‐tests for at‐home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention‐to‐treat analyses, adjusting for baseline HIV risk and marital status. Results Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person‐years (p‐yr) of follow‐up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p‐yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p‐yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]). Conclusions Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems