Patient actor training improves PrEP delivery for adolescent girls and young women in Kenya: a cluster randomized trial.

OBJECTIVE: To evaluate effectiveness of a standardized patient actor (SP) training intervention to improve quality of PrEP services for adolescent girls and young women (AGYW) in Kenya. DESIGN: Cluster randomized trial and mystery shopper evaluation. METHODS: Twelve of 24 maternal child health and family planning facilities were randomized to SP training. Providers at intervention facilities participated in 2-day training in adolescent health, PrEP guidelines, values clarification, and communication skills, followed by role-playing and de-briefing with trained actors. Control facilities received standard national training. The primary outcome was quality of care, assessed by unannounced SPs (USPs) or "mystery shoppers" blinded to intervention arm. Quality was measured in two domains: guideline adherence and communication skills. Intent to treat analysis compared post-intervention quality scores by randomization arm, clustering on facility, and adjusting for baseline scores and USP. RESULTS: Overall, 232 providers consented to USP visits, and 94 providers completed the training. Following training, USPs posed as AGYW seeking PrEP in 142 encounters (5-6 encounters per site). The mean quality score was 73.6% at intervention sites and 58.4% at control sites [adjusted mean difference=15.3, 95% Confidence interval (CI): 9.4-21.1, p < 0.001]. Mean guideline adherence scores were 57.2% at intervention sites and 36.2% at control sites (adjusted mean difference=21.0, 95% CI: 12.5-29.4, p < 0.001). Mean communication scores were 90.0% at intervention sites and 80.5% at control sites (adjusted mean difference=9.5, 95% CI: 5.5-13.6, p < 0.001). CONCLUSIONS: SP training significantly improved quality of PrEP care for AGYW in Kenya. Incorporating SP training and unannounced SP evaluation could improve PrEP uptake among AGYW.

An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya.

Background: Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization and the Kenyan Ministry of Health for HIV prevention in pregnancy and postpartum for women at risk for HIV. Integration of PrEP into antenatal care is promising, but delivery gaps exist in the face of healthcare provider shortages in resource-limited settings. Methods: Between May and November 2021, we conducted a difference-in-differences study (3 months pre-intervention data collection and 3 months post-intervention data collection) analyzing four intervention facilities, where the strategies were implemented, and four comparison facilities, where no strategies were implemented. We tested a combination of three implementation strategies-video-based PrEP information in the waiting bay, HIV self-testing, and dispensing of PrEP in the antenatal care rooms-to improve PrEP delivery. We compared absolute changes in the proportion of antenatal attendees screened for PrEP (PrEP penetration), the proportion receiving all PrEP-specific steps in a visit (HIV testing, risk screening, and PrEP counseling) (PrEP fidelity), and client PrEP knowledge, client satisfaction, and waiting time and service time (a priori outcomes); post hoc, we compared the proportion offered PrEP (PrEP offer) and completing HIV testing. We measured provider perceptions of the acceptability and appropriateness of the implementation strategies. Results: We observed significant improvements in PrEP penetration, PrEP offer, satisfaction, and knowledge (p < 0.05) and improvements in fidelity that trended towards significance (p = 0.057). PrEP penetration increased 5 percentage points (p = 0.008), PrEP fidelity increased 8 percentage points (p = 0.057), and PrEP offer increased 4 percentage points (p = 0.003) in intervention vs. comparison facilities. Client PrEP knowledge increased by 1.7 out of 6 total points (p < 0.001) and client satisfaction increased by 0.7 out of 24 total points (p = 0.003) in intervention vs. comparison facilities. We observed no changes in service time (0.09-min decrease; p = 0.435) and a small increase in waiting time (0.33-min increase; p = 0.005). HIV testing among those eligible did not change (1.5 percentage point decrease, p = 0.800). Providers felt the implementation strategies were acceptable and appropriate (median acceptability: 20/20; median appropriateness: 19.5/20). However, absolute levels of each step of the PrEP cascade remained suboptimal. Conclusions: An implementation strategy package with video information, HIV self-testing, and co-location of medication dispensing enhanced PrEP delivery across several implementation outcomes and client satisfaction, while not substantially increasing wait time or decreasing provider-client contact time. Clinical trial registration: ClinicalTrials.gov , identifier, NCT04712994.

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

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.

Integrating PrEP in maternal and child health clinics in Kenya: analysis of a service availability and readiness assessment (SARA) survey.

Background: Risk of HIV acquisition is high during pregnancy and postpartum, and pre-exposure prophylaxis (PrEP) is recommended for peripartum populations. Integrating PrEP into maternal and child health (MCH) clinics is feasible and acceptable. Understanding clinics' service availability and readiness is essential for effective scale up. Methods: The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged PrEP-experienced facilities previously linked to a programmatic or research study in Western Kenya to document available services and commodities via a modified service availability and readiness assessment (SARA) survey with 20 PrEP tracer items covering: staffing/guidelines, services/equipment, and medicines/commodities. Facilities' prior study engagement occurred between 2017 and 2019; SARA survey data was collected between April 2020 and June 2021. Descriptive statistics were stratified by prior study engagement. ANOVA tests assessed associations between facility characteristics and gaps. Fisher's tests assessed differences in commodity availability and stockouts. Results: Of the 55 facilities surveyed, 60% had received PrEP training in the last two years, 95% offered PrEP integrated into MCH, and 64% and 78% had both auditory and visual privacy in PrEP and HIV testing service (HTS) delivery spaces, respectively. Supervision frequency was heterogeneous, but 82% had received a supervision visit within 3 months. Availability of commodities was variable and the most commonly unavailable commodities were PrEP in MCH (71% available) and risk assessment screening tool (RAST) and PrEP cards (60% and 75% available, respectively). The number of service and commodity gaps per facility ranged from zero to eight (median: 3; IQR: 2, 5). The most frequent gaps were: PrEP training and risk assessment cards (40% each), lack of privacy in PrEP (36%) and HIV testing services (31%) spaces, PrEP pills in MCH (29%), and PrEP cards (25%). There were no differences in mean number of gaps by county, previous study engagement, or public vs. private status. Level 4 facilities had fewer gaps (mean 2.2) than level 2, 3, and 5 facilities (mean 5.7, 4.5, and 5.3 respectively; p < 0.001). Conclusions: PrEP service availability and readiness was generally high across MCH facilities. However, there is a need for increased frequency of provider training and supportive supervision focused on fidelity. To address key commodity stockouts such as PrEP pills, implementation of electronic logistics management information systems may be needed. Targeting these gaps is essential to effectively scale up integrated PrEP delivery, especially among facilities with limited infrastructure.

Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study.

BACKGROUND: There is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting. METHODS: We engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) "past experience surveys" with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) "pre- and post-small-group ranking" surveys before and after group discussion (N = 44 and 40); (4) "go-zone" quadrant plots of perceived effectiveness vs feasibility. Kendall's correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey. RESULTS: The strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p < 0.001). There was moderate correlation between go-zone plots and post-small-group rankings (Tau: 0.363; p = 0.079) and between past-experience surveys and post-small-group rankings (Tau: 0.385; p = 0.062). For strategy bundling, participants primarily chose bundles of strategies in the order in which they were listed, reflecting option ordering bias. Neither the phone nor online approach was effective in selecting strategy bundles. Participants agreed that the strategy ranking activities conducted during the workshop were useful in prioritizing a final set of strategies. CONCLUSIONS: Both experienced and inexperienced stakeholder participants' strategy rankings tended to prioritize strategies perceived as feasible. Small group discussions focused on feasibility and effectiveness revealed moderately different priorities than individual rankings. The strategy bundling approach, though less time- and resource-intensive, was not effective. Future research should further compare the relative effectiveness and pragmatism of methodologies to prioritize implementation strategies.

Mystery Shopper Assessment of PrEP Service Delivery Quality for Adolescent Girls and Young Women in Kenya: A Cross-sectional Study.

ABSTRACT: Pre-exposure prophylaxis (PrEP) uptake and adherence among adolescent girls and young women (AGYW) may be negatively influenced by poor interactions with health care providers. We assessed PrEP counseling using unannounced standardized patient actors (USPs) at routine care clinics in Kenya. Trained actors posed as AGYW seeking PrEP services following case scripts and completed a checklist of provider adherence to national guidelines and communication skills. Scores were converted into a percentage and compared using linear regression. The overall mean quality score was 52.1 and varied across case scripts: a married new initiator yielded higher scores than portrayals of adherence/stigma challenges, transactional sex, and a minor adolescent. Mean guideline scores (31.4) were lower than communication scores (72.8), although in 36.5% of encounters, USPs stated they would not seek help from that provider again. Unannounced standardized patients reported provider reluctance to offer PrEP to AGYW. Interventions to strengthen provider counseling skills are needed.

Improving Quality of PrEP Counseling for Adolescent Girls and Young Women in Kenya With Standardized Patient Actors: A Dose-Response Analysis.

BACKGROUND: Health care worker (HCW) training using standardized patient actors (SPs) is an evidence-based approach for improving patient-provider interactions. We evaluated whether SP training among HCWs in Western Kenya improved the quality of pre-exposure prophylaxis (PrEP) counseling for adolescent girls and young women (AGYW). METHODS: We conducted a 2-day SP training intervention among HCWs providing PrEP counseling for AGYW. Six trained SPs role played one encounter each with HCWs following scripts depicting common PrEP-seeking scenarios. SPs used checklists to report and discuss domains of adherence to national PrEP guidelines, communication, and interpersonal skills using validated scales after each encounter. HCWs presented to each case in a random order. Overall and domain-specific mean score percentages were compared between the first and subsequent case encounters using generalized linear models, clustering by HCWs. RESULTS: During 564 training cases among 94 HCWs, the overall mean quality of PrEP counseling score was 83.1 (SD: 10.1); scores improved over the course of the 6 encounters (P < 0.001). Compared with the first case encounter, the mean scores for the fourth were significantly higher (79.1 vs. 85.9, P < 0.001). The mean scores plateaued from the fourth to the sixth case (85.2). Although HCWs demonstrated high baseline communication (95.3) and interpersonal skills (83.7), adherence to PrEP guidelines at baseline was suboptimal (57.6). By the fourth case, scores increased significantly (P < 0.001) for all domains. CONCLUSIONS: SP training improved PrEP counseling overall and in domains of interpersonal skills, use of guidelines, and communication with AGYW and could be useful in efforts to improve the quality of PrEP counseling for AGYW.

Contraceptive Method Mix and HIV Risk Behaviors Among Kenyan Adolescent Girls and Young Women Seeking Family Planning Services: Implications for Integrating HIV Prevention.

Background: Understanding HIV risk behaviors among adolescent girls and young women (AGYW) seeking contraception could help inform integrating HIV prevention services within family planning (FP) clinics. Methods: From 10/2018 to 04/2019, we conducted a survey at 4 FP clinics in Kisumu, Kenya to evaluate risk behaviors among AGYW without HIV infection seeking contraception. All AGYW aged 15-24 were invited to participate following receipt of FP services. Adolescent girls and young women initiating or refilling contraception were included in this analysis. Long-acting reversible contraceptives (LARC) included intrauterine devices, implants, or injectables. Non-LARC methods included oral contraceptive pills (OCP) or condoms. We used an empiric risk score to assess HIV risk behaviors; HIV risk scores of ≥5 (corresponding to 5-15% HIV incidence) defined "high" HIV risk. Results: Overall, 555 AGYW seeking FP were included. Median age was 22 years [interquartile range (IQR) 20-23], median completed education was 12 years (IQR 10-12); 23% of AGYW had HIV risk scores of ≥5. The most frequent form of contraception was injectables (43%), followed by implants (39%). After adjustment for education, prior pregnancy, and marital status, LARC users more frequently engaged in transactional sex than non-LARC users [6 vs. 0%, adjusted prevalence ratio (PR) = 1.17, 95% CI 1.09-1.29, p < 0.001]; LARC use was not associated with HIV risk scores ≥5. Among LARC users, AGYW using injectables more frequently had condomless sex compared to AGYW using other LARC methods (85 vs. 75%, adjusted PR = 1.52, 95% CI 1.09-2.10, p = 0.012); injectable use was not associated with HIV risk scores ≥5. Conclusions: Adolescent girls and young women seeking contraception frequently had high HIV risk, emphasizing the importance of integrating HIV prevention within FP. Multipurpose technologies for contraception and HIV prevention could particularly benefit AGYW.

High Awareness, Yet Low Uptake, of Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women Within Family Planning Clinics in Kenya.

Adolescent girls and young women (AGYW) are a priority population for HIV prevention in high-burden settings. We evaluated psychosocial characteristics, behavioral risk factors for HIV, and pre-exposure prophylaxis (PrEP) awareness and uptake among AGYW seeking contraceptive services at four public sector family planning (FP) clinics offering integrated PrEP delivery in Kisumu, Kenya. From October 2018 to June 2019, we approached all AGYW (aged 15-24 years) seeking contraception to participate in a survey following receipt of FP services and PrEP screening. Overall, 470 AGYW were screened for PrEP at their FP visit by facility staff and subsequently enrolled in the survey. Median age was 22 years (interquartile range 20-23), 22% of AGYW were in school, and 55% were married. The most frequent forms of contraception were implants and injectables (41% each). Over a third of AGYW (36%) reported low social support, 13% had symptoms of moderate to severe depression, and 3% reported intimate partner violence. Three-quarters (75%) of AGYW reported recent condomless sex and 42% suspected that their primary partner had other sexual partners. Most AGYW (89%) had previously heard of PrEP; 76% had at least one PrEP eligibility criterion as per national guidelines; however, only 4% initiated PrEP at their current FP visit. PrEP initiators more frequently had high HIV risk perception than noninitiators (85% vs. 10%, p < 0.001). Low perceived HIV risk (76%) and pill burden (51%) were common reasons for declining PrEP among AGYW with HIV behavioral risk factors. PrEP counseling should be tailored to AGYW to guide appropriate PrEP decision-making in this important population.

Depression and HIV risk behaviors among adolescent girls and young women seeking family planning services in Western Kenya.

We assessed prevalence of human immunodeficiency virus (HIV) risk behaviors and depressive symptoms among adolescent girls and young women (AGYW) aged 15-24 years attending four public family planning clinics in Western Kenya from January to June 2019. Moderate-to-severe depression (MSD) was defined as a Center for Epidemiologic Studies Depression Scale (CESD-10) score ≥10. Among 487 AGYW, the median age was 22 years (interquartile range 20-23), and 59 (12%) AGYW reported MSD. MSD was more prevalent among AGYW without a current partner (p = 0.001) and associated with HIV risk factors including partner ≥10 years older, recent transactional sex, forced sex, intimate partner violence, and alcohol use (each p ≤ 0.005). Thirty-four percent of AGYW with MSD had a high HIV risk score corresponding to 5 to 15 incident HIV cases per 100 person-years. Overlapping high prevalence of depression and HIV risk among AGYW underscores the need for integrated mental health and HIV services in family planning clinics.

Two-Way Short Message Service (SMS) Communication May Increase Pre-Exposure Prophylaxis Continuation and Adherence Among Pregnant and Postpartum Women in Kenya.

INTRODUCTION: We evaluated a 2-way short message service (SMS) communication platform to improve continuation of pre-exposure prophylaxis (PrEP) for HIV prevention among Kenyan women who initiated PrEP within routine maternal child health (MCH) and family planning clinics. METHODS: We adapted an existing SMS platform (Mobile WACh [mWACh]) to send PrEP-tailored, theory-based SMS and allow clients to communicate with a remote nurse. Women who did not have HIV and who were initiating PrEP at 2 MCH/family planning clinics in Kisumu County, Kenya, from February to October 2018, were offered enrollment into the mWACh-PrEP program; SMS communication was free. We evaluated acceptability, satisfaction, and implementation metrics. In a pre/postevaluation, we compared PrEP continuation at 1-month postinitiation among women who initiated PrEP in the period before (n=166) versus after mWACh-PrEP implementation, adjusting for baseline differences. RESULTS: Of the 334 women who were screened for enrollment into the mWACh-PrEP program; 193 (58%) were eligible and of those, 190 (98%) accepted enrollment. Reasons for ineligibility (n=141) included no phone access (29%) and shared SIM cards (25%). Median age was 25 years (interquartile range=22-30), and 91% were MCH clients. Compared to women who initiated PrEP in the month before mWACh-PrEP implementation, women who enrolled in mWACh-PrEP were more likely to return for their first PrEP follow-up visit (40% vs. 53%; adjusted risk ratio [aRR]=1.26; 95% confidence interval [CI]= 1.06, 1.50; P=.008) and more likely to continue PrEP (22% vs. 43%; aRR=1.75; 95% CI=1.21, 2.55; P=.003). Among those who returned, 99% reported successful receipt of SMS through the mWACh-PrEP system and 94% reported that mWACh-PrEP helped them understand PrEP better. Concerns about PrEP use, how it works, and side effects accounted for the majority (80%) of issues raised by participants using SMS. CONCLUSIONS: Two-way SMS expanded support for PrEP and opportunities for dialogue beyond the clinic and enabled women to ask and receive answers in real time regarding PrEP, which facilitated its continued use.

Frequency and Predictors of Tenofovir-diphosphate Detection Among Young Kenyan Women in a Real-world Pre-exposure Prophylaxis Implementation Program.

In a pre-exposure prophylaxis program for Kenyan women, we detected tenofovir-diphosphate in 61% (125/201) of randomly selected dried blood spots collected at the first follow-up visit. Tenofovir-diphosphate was detected more frequently among women who had partners living with human immunodeficiency virus, who were not pregnant, and who were ≥24 years.

Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya.

INTRODUCTION: The World Health Organization, while recommending pre-exposure prophylaxis (PrEP) for HIV-negative pregnant and postpartum women in HIV high-burden settings, advocates for continued safety evaluation of PrEP in this population. METHODS: The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self-reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother-infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. RESULTS: The PrIYA evaluation identified 1530 postpartum mother-infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP-exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large-scale programmatic implementation of PrEP among pregnant and postpartum populations. CONCLUSIONS: Pregnancy outcomes and early infant growth did not differ by PrEP exposure.