Providing HIV-assisted partner services to partners of partners in western Kenya: an implementation science study.

INTRODUCTION: Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of persons diagnosed HIV positive (index clients), is recommended by the World Health Organization. Most APS literature focuses on outcomes among index clients and their partners. There is little data on the benefits of providing APS to partners of partners diagnosed with HIV. METHODS: We utilized data from a large-scale APS implementation project across 31 facilities in western Kenya from 2018 to 2022. Females testing HIV positive at facilities were offered APS; those who consented provided contact information for all male sexual partners in the last 3 years. Male partners were notified of their potential HIV exposure and offered HIV testing services (HTS). Males newly testing positive were also offered APS and asked to provide contact information for their female partners in the last 3 years. Female partners of male partners (FPPs) were provided exposure notification and HTS. All participants with HIV were followed up at 12 months post-enrolment to assess linkage-to antiretroviral treatment (ART) and viral suppression. We compared HIV positivity, demographics and linkage outcomes among female index clients and FPPs. RESULTS: Overall, 5708 FPPs were elicited from male partners, of whom 4951 received HTS through APS (87% coverage); 291 FPPs newly tested HIV positive (6% yield), an additional 1743 (35.2%) reported a prior HIV diagnosis, of whom 99% were on ART at baseline. At 12 months follow-up, most FPPs were taking ART (92%) with very few adverse events: <1% reported intimate partner violence or reported relationship dissolution. FPPs were more likely than female index clients to report HIV risk behaviours including no condom use at last sex (45% vs. 30%) and multiple partners (38% vs. 19%). CONCLUSIONS: Providing HIV testing via APS to FPP is a safe and effective strategy to identify newly diagnosed females and achieve high linkage and retention to ART and can be an efficient means of identifying HIV cases in the era of declining HIV incidence. The high proportion of FPPs reporting HIV risk behaviours suggests APS may help interrupt community HIV transmission via increased knowledge of HIV status and linkage to treatment.

Effectiveness of HIV self-testing when offered within assisted partner services in Western Kenya (APS-HIVST Study): a cluster randomized controlled trial.

INTRODUCTION: Assisted partner services (APS) is an effective strategy for increasing HIV testing, new diagnosis, and linkage to care among sexual partners of people living with HIV (PLWH). APS can be resource intensive as it requires community tracing to locate each partner named and offer them testing. There is limited evidence for the effectiveness of offering HIV self-testing (HIVST) as an option for partner testing within APS. METHODS: We conducted a cluster randomized controlled trial comparing provider-delivered HIV testing (Standard APS) versus offering partners the option of provider-delivered testing or HIVST (APS+HIVST) at 24 health facilities in Western Kenya. Facilities were randomized 1:1 and we conducted intent-to-treat analyses using Poisson generalized linear mixed models to estimate intervention impact on HIV testing, new HIV diagnoses, and linkage to care. All models accounted for clustering at the clinic level and new diagnoses and linkage models were adjusted for individual-level age, sex, and income a priori. RESULTS: From March to December 2021, 755 index clients received APS and named 5054 unique partners. Among these, 1408 partners reporting a prior HIV diagnosis were not eligible for HIV testing and were excluded from analyses. Of the remaining 3646 partners, 96.9% were successfully contacted for APS and tested for HIV: 2111 (97.9%) of 2157 in the APS+HIVST arm and 1422 (95.5%) of 1489 in the Standard APS arm. In the APS+HIVST arm, 84.6% (1785/2111) tested via HIVST and 15.4% (326/2111) received provider-delivered testing. Overall, 16.7% of the 3533 who tested were newly diagnosed with HIV (APS+HIVST = 357/2111 [16.9%]; Standard APS = 232/1422 [16.3%]). Of the 589 partners who were newly diagnosed, 90.7% were linked to care (APS+HIVST = 309/357 [86.6%]; Standard APS = 225/232 [97.0%]). There were no significant differences between the two arms in HIV testing (relative risk [RR]: 1.02, 95% CI: 0.96-1.10), new HIV diagnoses (adjusted RR [aRR]: 1.03, 95% CI: 0.76-1.39) or linkage to care (aRR: 0.88, 95% CI: 0.74-1.06). CONCLUSIONS: There were no differences between APS+HIVST and Standard APS, demonstrating that integrating HIVST into APS continues to be an effective strategy for identifying PLWH by successfully reaching and HIV testing >95% of elicited partners, newly diagnosing with HIV one in six of those tested, >90% of whom were linked to care. CLINICAL TRIAL NUMBER: NCT04774835.

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial.

BACKGROUND: In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. DISCUSSION: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya.

Background: Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery. Methods: We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them. Results: Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments. Conclusions: HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

"I feel good because I have saved their lives": Acceptability of assisted partner services among female index clients and male sexual partners in Kenya.

INTRODUCTION: Assisted partner services (APS), or notification for sexual partners of people diagnosed with HIV, is an efficient, effective, and high yield strategy to identify people living with HIV and is recommended by the World Health Organization (WHO). However, there remains a need to further understand the acceptability of APS qualitatively from a client lens, particularly when APS is integrated into the national health system. We investigated acceptability of APS when integrated into HIV services in Kenya. METHODS: Starting in May 2018, APS was implemented in 31 health facilities in Kisumu and Homa Bay counties in western Kenya. From January to December 2019, we conducted in-depth interviews (IDIs) with female index clients (n = 16) and male sexual partners (n = 17) in 10 facilities participating in an APS scale up study. Interviews assessed APS satisfaction, perceived benefits of the intervention, and challenges that may affect delivery or uptake. We applied the Theoretical Framework of Acceptability by Sekhon et al. (2017) as a guide to organize our findings. RESULTS: We find that views of APS are often guided by an individual's trust in the intervention's design and implementation, and an interest to preserve one's health and that of one's family and children. There were strong and consistent acceptable views of APS as "doing good" and "saving a life" and as a means of showing love towards one's partner(s). The initial acceptability framing of individuals engaging with APS was predicated either on a feeling of comfort with the intervention, or a wariness of divulging sex partner personal information. Health care workers (HCWs) were seen to play an important role in mitigating participant fears linked with the intervention, particularly around the sensitive nature of HIV disclosure and sexual partners. Clients noted considerable challenges that affected acceptability, including the risk to the relationship of disclosing one's HIV status, and the risk of intimate partner violence. DISCUSSION: We found that APS is acceptable as a strategy to reach male sexual partners of females diagnosed with HIV, and these findings provide opportunities to inform recommendations for further scale-up. Opportunities such as focusing on intervention confidentiality and appropriate counseling, excluding female clients at risk of IPV from this intervention, and highlighting the altruistic benefits of APS to potential clients. Understanding the perspectives of clients receiving APS in a real-world setting may be valuable to policy-makers and stakeholders interested in scaling up or enhancing APS within health systems.

Implementation fidelity to HIV assisted partner services (aPS) during scale-up in western Kenya: a convergent mixed methods study.

BACKGROUND: HIV assisted partner services (aPS) is an intervention to improve HIV status awareness among sex and drug-injecting partners of people newly diagnosed with HIV (index clients). Implementation fidelity-the degree to which an intervention is conducted as intended - is critical to effectiveness, but there are limited data about aPS fidelity when delivered by HIV testing service (HTS) providers. We explored factors affecting implementation fidelity to aPS in two high-HIV prevalence counties in western Kenya. METHODS: We used convergent mixed methods adapting the conceptual framework for implementation fidelity within the aPS scale-up project. This was an implementation study examining scale-up of APS within HTS programs in Kisumu and Homa Bay counties that recruited male sex partners (MSPs) of female index clients. We defined implementation fidelity as the extent to which HTS providers followed the protocol for phone and in-person participant tracing at six expected tracing attempts. Quantitative data were collected from tracing reports in 31 facilities between November 2018 and December 2020, and in-depth interviews (IDIs) were conducted with HTS providers. Descriptive statistics were used to describe tracing attempts. IDIs were analyzed using thematic content analysis. RESULTS: Overall, 3017 MSPs were mentioned of whom 98% (2969/3017) were traced, with most tracing attempts being successful (2831/2969, 95%). Fourteen HTS providers participated in the IDIs-mostly females (10/14, 71%) with a median age of 35 years (range 25-52), who all had post-secondary education (14/14, 100%). The proportion of tracing attempts occurring by phone ranged from 47 to 66%, with the highest proportion occurring on the first attempt and lowest on the sixth attempt. Contextual factors either enhanced or impeded implementation fidelity to aPS. Positive provider attitudes towards aPS and conducive work environment factors promoted implementation fidelity, while negative MSP responses and challenging tracing conditions impeded it. CONCLUSION: Interactions at the individual (provider), interpersonal (client-provider), and health systems (facility) levels affected implementation fidelity to aPS. As policymakers prioritize strategies to reduce new HIV infections, our findings highlight the importance of conducting fidelity assessments to better anticipate and mitigate the impact of contextual factors during the scale-up of interventions.

Real-world impact of integrating HIV assisted partner services into 31 facilities in Kenya: a single-arm, hybrid type 2 implementation-effectiveness study.

BACKGROUND: Assisted partner services (APS), or exposure notification and HIV testing for sexual partners of individuals diagnosed with HIV (index clients), have been shown to be safe and effective in clinical trials. We assessed the real-world effectiveness of APS when integrated into HIV clinics in western Kenya. METHODS: In this single-arm, hybrid type 2 implementation science study, we facilitated APS implementation in 31 health facilities in Kenya by training existing health-care staff. We focused on male partner outcomes to assess the impact of APS in reaching male individuals in sub-Saharan Africa, who have lower rates of HIV testing than female individuals. Female individuals (aged ≥18 years or emancipated minor) who tested positive for HIV at participating facilities in Kenya were offered APS; consenting female participants provided contact information for all male sexual partners in the past 3 years. Male partners were notified of their potential HIV exposure and offered a choice of community-based or facility-based HIV testing services (HTS). Female index clients and male partners with HIV were followed up at 6 weeks, 6 months, and 12 months after enrolment, to assess linkage to antiretroviral treatment. Viral load was assessed at 12 months. FINDINGS: Between May 1, 2018, and March 31, 2020, 32 722 female individuals received HTS; 1910 (6%) tested positive for HIV, of whom 1724 (90%) received APS. Female index clients named 5137 male partners (median 3 per index [IQR 2-4]), of whom 4422 (86%) were reached with exposure notification and HTS. 524 (12%) of the male partners tested were newly diagnosed with HIV and 1292 (29%) reported a previous HIV diagnosis. At 12 months follow-up, 1512 (88%) female index clients and 1621 (89%) male partners with HIV were taking ART, with few adverse events: 25 (2%) female index clients and seven (<1%) male partners reported intimate partner violence, and 60 (3%) female index clients and ten (<1%) male partners reported relationship dissolution. INTERPRETATION: Evidence from this real-world APS scale-up project shows that APS is a safe, acceptable, and effective strategy to identify males with HIV and retain them in care. FUNDING: The US National Institutes of Health.

Integration of assisted partner services within Kenya's national HIV testing services program: A qualitative study.

Assisted partner service (aPS) augments HIV case-finding among sex partners to individuals newly diagnosed with HIV. In 2016, aPS was incorporated into the national HIV testing services (HTS) program in Kenya. We evaluated the extent of, barriers to, and facilitators of aPS integration into HTS. We conducted semi-structured in-depth interviews (IDIs) with 32 stakeholders selected using purposive sampling at national, county, facility, and community levels. IDIs were conducted at two timepoints, at baseline from August-September 2018 in Kisumu and January-June 2019 in Homa Bay, and at follow-up from May-August 2020 to understand changes in aPS integration over time. We defined integration as the creation of linkages between the new intervention (aPS) and the existing HTS program. Data were analyzed using thematic content analysis. We found varying degrees of aPS integration, highest in procurement/logistics and lowest in HTS provider recruitment/training. At baseline, aPS integration was low and activities were at an introductory phase. At follow-up, aPS was integrated in almost the entire HTS program with the exception of low community awareness, which was noted at both baseline and follow-up. There was increasing routinization with establishment of clear aPS cycles, e.g., quarterly data review meetings, annual budget cycles and work-plans. Major barriers included limited government funding, staff constraints, and inadequate community-level sensitization, while key facilitators included increased resources for aPS, and community health volunteer (CHV) facilitated awareness of aPS. Varying degrees of aPS integration across different units of the national HTS program highlights challenges in funding, human resource, and public awareness. Policymakers will need to address these barriers to ensure optimal provision of aPS.

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.

"It is a process" - a qualitative evaluation of provider acceptability of HIV assisted partner services in western Kenya: experiences, challenges, and facilitators.

BACKGROUND: Assisted partner service (APS) is effective for increasing HIV testing services (HTS) uptake among sexual partners of people diagnosed with HIV with rare social harm. The acceptability of APS to HTS providers is important for the quality and effectiveness of APS delivery. Within a larger ongoing implementation science study of APS in western Kenya, we qualitatively evaluated the provider acceptability of APS. METHODS: From May-June 2020, we conducted virtual, semi-structured in-depth interviews with 14 HTS providers recruited from 8 of 31 study health facilities in Homa Bay and Kisumu counties. Participants were selected using criteria-based purposive sampling to maximize variation on patient volume (assessed by the number of index clients tested for HIV) and APS performance (assessed by sexual partners elicitation and enrollment). Interviews inquired providers' experiences providing APS including challenges and facilitators and the impact of contextual factors. Data were analyzed using an inductive approach. RESULTS: Overall, HTS providers found APS acceptable. It was consistently reported that doing APS was a continuous process rather than a one-day job, which required building rapport and persistent efforts. Benefits of APS including efficiency in HIV case finding, expanded testing coverage in men, and increased HIV status awareness and linkage to care motivated the providers. Provider referral was perceived advantageous in terms of independent contact with partners on behalf of index clients and efficiency in partner tracing. Challenges of providing APS included protecting clients' confidentiality, difficulty obtaining partners' accurate contact information, logistic barriers of tracing, and clients' refusal due to fear of being judged for multiple sexual partners, fear of breach of confidentiality, and HIV stigma. Building rapport with clients, communicating with patience and nonjudgmental attitude and assuring confidentiality were examples of facilitators. Working in rural areas and bigger facilities, training, supportive supervision, and community awareness of APS promoted APS delivery while low salaries, lack of equipment, and high workload undermined it. CONCLUSIONS: HTS providers found APS acceptable. Delivering APS as a process was the key to success. Future scale-up of APS could consider encouraging provider referral instead of the other APS methods to improve efficiency and reduce potential harm to clients.

Cost of integrating assisted partner services in HIV testing services in Kisumu and Homa Bay counties, Kenya: a microcosting study.

BACKGROUND: HIV assisted partner services (aPS), or provider notification and testing for sexual and injecting partners of people diagnosed with HIV, is shown to be safe, effective, and cost-effective and was scaled up within the national HIV testing services (HTS) program in Kenya in 2016. We estimated the costs of integrating aPS into routine HTS within an ongoing aPS scale-up project in western Kenya. METHODS: We conducted microcosting using the payer perspective in 14 facilities offering aPS. Although aPS was offered to both males and females testing HIV-positive (index clients), we only collected data on female index clients and their male sex partners (MSP). We used activity-based costing to identify key aPS activities, inputs, resources, and estimated financial and economic costs of goods and services. We analyzed costs by start-up (August 2018), and recurrent costs one-year after aPS implementation (Kisumu: August 2019; Homa Bay: January 2020) and conducted time-and-motion observations of aPS activities. We estimated the incremental costs of aPS, average cost per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy, cost shares, and costs disaggregated by facility. RESULTS: Overall, the number of MSPs traced, tested, testing HIV-positive, and on antiretroviral therapy was 1027, 869, 370, and 272 respectively. Average unit costs per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy were $34.54, $42.50, $108.71 and $152.28, respectively, which varied by county and facility client volume. The weighted average incremental cost of integrating aPS was $7,485.97 per facility per year, with recurrent costs accounting for approximately 90% of costs. The largest cost drivers were personnel (49%) and transport (13%). Providers spent approximately 25% of the HTS visit obtaining MSP contact information (HIV-negative clients: 13 out of 54 min; HIV-positive clients: 20 out of 96 min), while the median time spent per MSP traced on phone and in-person was 6 min and 2.5 hours, respectively. CONCLUSION: Average facility costs will increase when integrating aPS to HTS with incremental costs largely driven by personnel and transport. Strategies to efficiently utilize healthcare personnel will be critical for effective, affordable, and sustainable aPS.

Using Assisted Partner Services for HIV Testing and the Treatment of Males and Their Female Sexual Partners: Protocol for an Implementation Science Study.

BACKGROUND: Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting. OBJECTIVE: This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya. METHODS: Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases. RESULTS: As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic. CONCLUSIONS: The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27262.

High Acceptability of Assisted Partner Notification Services Among HIV-Positive Females in Kenya: Results From an Ongoing Implementation Study.

BACKGROUND: Assisted partner services (aPS) involves notification and HIV testing for sexual partners of persons diagnosed HIV-positive (index clients). Because the impact of aPS is contingent on high acceptance, we assessed characteristics and reasons for nonenrollment among female index clients in an ongoing scale-up project. METHODS: We analyzed data from HIV-positive females offered aPS in 31 facilities from May 2018 to August 2019. We compared sociodemographic characteristics by aPS enrollment (accepted, refused, and ineligible) and used multivariate binomial regression to assess associations between demographics and refusal. RESULTS: Twenty-four thousand four hundred eighteen females received HIV testing and 1050 (4.3%) tested HIV-positive; 839 females enrolled in aPS (80%), 59 refused (6%), and 152 were ineligible (14%). APS uptake did not differ by age, testing history, or testing type (provider initiated vs. client initiated). Females refusing aPS were more likely to have completed secondary school [adjusted relative risk (aRR) 2.03, 95% confidence interval (CI): 1.13 to 2.82] and be divorced/separated (aRR: 3.09, 95% CI: 1.39 to 6.86) or single (aRR: 2.66, 95% CI: 1.31 to 5.42) compared with married/cohabitating. Reasons for refusing aPS included not feeling emotionally ready (31%) and reporting no sexual partners in past 3 years (22%). Reasons for ineligibility included fear or risk of intimate partner violence (9%), previous HIV diagnosis (9%), or insufficient time for aPS provision (3%). CONCLUSIONS: APS has high acceptability among HIV-positive females regardless of age or testing history. More counseling may be needed to increase uptake among females with higher education and those who are separated/single. Follow-up for females not emotionally ready or who had insufficient time for aPS in their clinic visit can improve coverage.

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.

Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.

INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies. METHODS AND ANALYSIS: PrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group. ETHICS AND DISSEMINATION: The protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT03875950.

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.

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.

BACKGROUND: Pregnant women in settings with high HIV prevalence are at increased risk of HIV acquisition and subsequent vertical transmission. We implemented and evaluated a novel programme to provide pre-exposure prophylaxis (PrEP) in maternal and child health clinics in Kenya. METHODS: In collaboration with Kisumu County Department of Health, we integrated PrEP delivery within 16 maternal and child health clinics in Kisumu County (Kenya). Women and girls older than 15 years seeking maternal and child health services who tested HIV negative at that visit or within a month and were willing to receive PrEP counselling were interviewed to assess for HIV behavioural risk factors and offered PrEP. Correlates of PrEP initiation and continuation were assessed using Poisson regression in univariate and multivariate analyses. Potential correlates included in our analyses were age, marital status, marriage type, whether pregnant or post partum, gestational age (if pregnant), and HIV risk factors in the previous 6 months. Reasons for the decision to discontinue after having decided to initiate PrEP were evaluated. Women who initiated PrEP were followed up 1 month, 3 months, and 6 months after initiation. FINDINGS: Between Nov 20, 2017, and June 13, 2018, 9376 pregnant and post-partum women were assessed for behavioural risk factors and willingness to initiate PrEP. Overall, 2030 (21·7%) initiated PrEP, and 2027 had the status of their partner captured (153 [79·3%] of 193 women with partners living with HIV, 1178 [37·2%] of 3165 women with partners of unknown HIV status, and 696 [11·6%] of 5997 women with HIV-negative partners). Predictors of PrEP initiation in the multivariate analysis were: being younger than 24 years (adjusted prevalence ratio 1·14, 95% CI 1·02-1·28); having a partner living with HIV (6·96, 5·46-8·89) or of unknown HIV status (3·08, 2·50-3·81); gestational age of less than 26 weeks (1·22, 1·02-1·47); having been diagnosed or treated for a sexually transmitted infection (1·57, 1·20-2·06); having been forced to have sex (1·82, 1·38-2·42); having experienced intimate partner violence during the previous 6 months (1·65, 1·10-2·48); having shared needles while engaging in injection drug use (2·43, 1·69-3·50); and recurrent use of post-exposure prophylaxis (1·96, 1·36-2·82). Overall, 786 (38·7%) of 2030 women who initiated PrEP continued use after the first month, with 104 (68·0%) of 153 women who had a partner living with HIV continuing use. Having a partner living with HIV was the only predictor of PrEP continuation at 1 month in the multivariable model (1·98, 1·54-2·55). Frequent reasons for discontinuation were side effects and low HIV risk perception. No incident HIV infection was reported among women on PrEP. INTERPRETATION: Many women attending maternal and child health clinics had risk factors for HIV and elected to use PrEP, indicating that routinely accessed maternal and child health clinics can be an effective platform for PrEP delivery for young women. As PrEP awareness rises, PrEP provision in routine clinical settings such as maternal and child health facilities might contribute to decreased HIV incidence among young women. FUNDING: US Department of State.