Drug concentrations in hair and dried blood spots as PrEP adherence metrics during pregnancy and postpartum.

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV pre-exposure prophylaxis (PrEP) during pregnancy and postpartum and compared hair levels with tenofovir-diphosphate (TFV-DP) levels in dried blood spots (DBS). Overall, 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster randomized trial. Having a partner known to be living with HIV was associated with higher hair TFV levels (p<0.001). Hair TFV concentrations were strongly correlated with DBS TFV-DP levels (r=0.76, p<0.001), indicating hair as promising cumulative adherence metric for perinatal PrEP assessment.

Correction: A Text Messaging-Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/41170.].

A Text Messaging-Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial.

BACKGROUND: Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and post partum. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir-based pre-exposure prophylaxis (PrEP) to pregnant and postpartum women who are HIV negative but at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence. OBJECTIVE: We are conducting a randomized controlled trial to determine the effect of a bidirectional communication platform named Mobile Solutions for Women's and Children's Health (mWACh), which utilizes two-way SMS text messaging between patients and remote nurses to support PrEP adherence and address maternal health concerns in real time during the peripartum period. METHODS: The mWACh-PrEP study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP to the standard of care (ie, in-clinic adherence counseling) among women who are HIV negative and initiating PrEP. Purposive sampling was used to select 5 facilities offering PrEP in antenatal clinics in Kisumu and Siaya Counties, and block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a customized messaging curriculum via SMS text messages targeted toward their particular perinatal stage. The primary outcome, PrEP adherence at 6 months post partum, will be evaluated using a log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir concentration cutoff of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6 months post partum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention. RESULTS: Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025. CONCLUSIONS: This trial will provide insights into using mobile health to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, the findings will have implications for the use of mobile health technology to improve adherence to other daily medications during the peripartum period. TRIAL REGISTRATION: ClinicalTrials.gov NCT04472884; https://clinicaltrials.gov/ct2/show/NCT04472884. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41170.

Healthworker preparedness for COVID-19 management and implementation experiences: a mixed methods study in Uganda's refugee-hosting districts.

BACKGROUND: The negative impact of COVID-19 on population health outcomes raises critical questions on health system preparedness and resilience, especially in resource-limited settings. This study examined healthworker preparedness for COVID-19 management and implementation experiences in Uganda's refugee-hosting districts. METHODS: A cross sectional, mixed-method descriptive study in 17 health facilities in 7 districts from 4 major regions. Total sample size was 485 including > 370 health care workers (HCWs). HCW knowledge, attitude and practices (KAP) was assessed by using a pre-validated questionnaire. The quantitative data was processed and analysed using SPSS 26, and statistical significance assumed at p < 0.05 for all statistical tests. Bloom's cutoff of 80% was used to determine threshold for sufficient knowledge level and practices with scores classified as high (80.0-100.0%), average (60.0-79.0%) and low (≤ 59.0%). HCW implementation experiences and key stakeholder opinions were further explored qualitatively using interviews which were audio-recorded, coded and thematically analysed. RESULTS: On average 71% of HCWs were knowledgeable on the various aspects of COVID-19, although there is a wide variation in knowledge. Awareness of symptoms ranked highest among 95% (p value < 0.0001) of HCWs while awareness of the criteria for intubation for COVID-19 patients ranked lowest with only 35% (p value < 0.0001). Variations were noted on falsehoods about COVID-19 causes, prevention and treatment across Central (p value < 0.0356) and West Nile (p value < 0.0161) regions. Protective practices include adequate ventilation, virtual meetings and HCW training. Deficient practices were around psychosocial and lifestyle support, remote working and contingency plans for HCW safety. The work environment has immensely changed with increased demands on the amount of work, skills and variation in nature of work. HCWs reported moderate control over their work environment but with a high level of support from supervisors (88%) and colleagues (93%). CONCLUSIONS: HCWs preparedness is inadequate in some aspects. Implementation of healthcare interventions is constrained by the complexity of Uganda's health system design, top-down approach of the national response to COVID-19 and longstanding health system bottlenecks. We recommend continuous information sharing on COVID-19, a design review with capacity strengthening at all health facility levels and investing in community-facing strategies.

The Utility of SMS to Report Male Partner HIV Self-testing Outcomes Among Women Seeking Reproductive Health Services in Kenya: Cohort Study.

BACKGROUND: Use of SMS for data collection is expanding, but coverage, bias, and logistical constraints are poorly described. OBJECTIVE: The aim of this study is to assess the use of SMS to capture clinical outcomes that occur at home and identify potential biases in reporting compared to in-person ascertainment. METHODS: In the PrEP Implementation in Young Women and Adolescents program, which integrated pre-exposure prophylaxis (PrEP) into antenatal care, postnatal care, and family planning facilities in Kisumu County, Kenya, HIV-negative women 14 years of age or older were offered oral HIV self-tests (HIVSTs) to take home to male partners. Women that brought a phone with a Safaricom SIM to the clinic were offered registration in an automated SMS system (mSurvey) to collect information on HIVST outcomes. Women were asked if they offered the test to their male partners, and asked about the test process and results. HIVST outcomes were collected via SMS (sent 2.5 weeks later), in-person (if women returned for a follow-up scheduled 1 month later), or using both methods (if women initiated PrEP, they also had scheduled follow-up visits). The SMS prompted women to reply at no charge. HIVST outcomes were compared between women with scheduled follow-up visits and those without (follow-up visits were only scheduled for women who initiated PrEP). HIVST outcomes were also compared between women reporting via SMS and in-person. RESULTS: Among 2123 women offered HIVSTs and mSurvey registration, 486 (23.89%) accepted HIVSTs, of whom 359 (73.87%) were eligible for mSurvey. Additionally, 76/170 (44.7%) women with scheduled follow-up visits and 146/189 (77.3%) without scheduled follow-up visits registered in mSurvey. Among the 76 women with scheduled follow-ups, 62 (82%) had HIVST outcomes collected: 19 (31%) in-person, 20 (32%) by SMS, and 23 (37%) using both methods. Among the 146 women without scheduled visits, 87 (59.6%) had HIVST outcomes collected: 3 (3%) in-person, 82 (94%) by SMS, and 2 (2%) using both methods. SMS increased the collection of HIVST outcomes substantially for women with scheduled follow-up visits (1.48-fold), and captured 82 additional reports from women without scheduled follow-up visits. Among 222 women with reported HIVST outcomes, frequencies of offering partners the HIVST (85/95, 89% in-person vs 96/102, 94% SMS; P=.31), partners using the HIVST (83/85, 98% vs 92/96, 96%; P=.50), women using HIVST with partners (82/83, 99% vs 91/92, 99%; P=.94), and seeing partner's HIVST results (82/83, 99% vs 89/92, 97%; P=.56) were similar between women reporting in-person only versus by SMS only. However, frequency of reports of experiencing harm or negative reactions from partners was more commonly reported in the SMS group (17/102, 16.7% vs 2/85, 2%; P=.003). Barriers to the SMS system registration included not having a Safaricom SIM or a functioning phone. CONCLUSIONS: Our results suggest that the use of SMS substantially improves completeness of outcome data, does not bias reporting of nonsensitive information, and may increase reporting of sensitive information. .

Index participant characteristics and HIV assisted partner services efficacy in Kenya: results of a cluster randomized trial.

INTRODUCTION: We have previously demonstrated that assisted partner services (aPS) increases HIV testing and case finding among partners of persons living with HIV (PLHIV) in a cluster randomized trial in Kenya. However, the efficacy of aPS may vary across populations. In this analysis, we explore differences in aPS efficacy by characteristics of index participants. METHODS: Eighteen HIV testing sites were randomized to immediate versus 6-week delayed aPS. Participants were PLHIV (or index participants) and their sexual partners. Partners of index participants were contacted for HIV testing and linked to care if HIV positive. Primary outcomes were the number of partners per index participant who: 1) tested for HIV, 2) tested HIV positive and 3) enrolled in HIV care. We used generalized estimating equations to assess differences in aPS efficacy by region, testing location, gender, age and knowledge of HIV status. RESULTS: From 2013 to 2015, the study enrolled 1119 index participants, 625 of whom were in the immediate group. These index participants named 1286 sexual partners. Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8). Higher rates of partner HIV testing were also observed for index participants in rural/peri-urban compared to urban sites (IRR 6.6; 95% CI 4.5, 9.6 vs. IRR 3.5 95% CI 2.5, 5.0 respectively), for female versus male index participants (IRR 5.8 95% CI 4.2, 7.9 vs. IRR 3.7; 95% CI 2.4, 5.8 respectively) and for newly diagnosed versus known HIV-positive index participants (IRR 6.0 95% CI 4.2, 8.7 vs. IRR 3.3; 95% CI 2.0, 7.7 respectively). Providing aPS to female versus male index participants also had a significantly higher HIV case finding rate (IRR 9.1; 95% CI 4.0, 20.9 vs. IRR 3.2 95% CI 1.7, 6.0 respectively.) CONCLUSIONS: While it is known that aPS promotes increases in HIV testing and case finding, this is the first study to demonstrate significant differences in aPS efficacy across characteristics of the index participant. Understanding these differences and their drivers will be critical as aPS is brought to scale in order to ensure all PLHIV have access to these services.

HIV partner services in Kenya: a cost and budget impact analysis study.

BACKGROUND: The elicitation of contact information, notification and testing of sex partners of HIV infected patients (aPS), is an effective HIV testing strategy in low-income settings but may not necessarily be affordable. We applied WHO guidelines and the International Society for Pharmaco-economics and Outcomes Research (ISPOR) guidelines to conduct cost and budget impact analyses, respectively, of aPS compared to current practice of HIV testing services (HTS) in Kisumu County, Kenya. METHODS: Using study data and time motion studies, we constructed an Excel-based tool to estimate costs and the budget impact of aPS. Cost data were collected from selected facilities in Kisumu County. We report the annual total and unit costs of HTS, incremental total and unit costs for aPS, and the budget impact of scaling up aPS over a 5-year horizon. We also considered a task-shifted scenario that used community health workers (CHWs) rather than facility based health workers and conducted sensitivity analyses assuming different rates of scale up of aPS. RESULTS: The average unit costs for HIV testing among HIV-infected index clients was US$ 25.36 per client and US$ 17.86 per client using nurses and CHWs, respectively. The average incremental costs for providing enhanced aPS in Kisumu County were US$ 1,092,161 and US$ 753,547 per year, using nurses and CHWs, respectively. The average incremental cost of scaling up aPS over a five period was 45% higher when using nurses compared to using CHWs (US$ 5,460,837 and US$ 3,767,738 respectively). Over the five years, the upper-bound budget impact of nurse-model was US$ 1,767,863, 63% and 35% of which were accounted for by aPS costs and ART costs, respectively. The CHW model incurred an upper-bound incremental cost of US$ 1,258,854, which was 71.2% lower than the nurse-based model. The budget impact was sensitive to the level of aPS coverage and ranged from US$ 28,547 for 30% coverage using CHWs in 2014 to US$ 1,267,603 for 80% coverage using nurses in 2018. CONCLUSION: Scaling aPS using nurses has minimal budget impact but not cost-saving over a five-year period. Targeting aPS to newly-diagnosed index cases and task-shifting to community health workers is recommended.

Brief Report: HIV Assisted Partner Services Among Those With and Without a History of Intimate Partner Violence in Kenya.

BACKGROUND: HIV assisted partner services (APS) are a notification and testing strategy for sex partners of HIV-infected index patients. This cluster-randomized controlled trial secondary data analysis investigated whether history of intimate partner violence (IPV) modified APS effectiveness and risk of relationship dissolution. SETTING: Eighteen HIV testing and counseling sites in Kenya randomized to provide immediate APS (intervention) or APS delayed for 6 weeks (control). METHODS: History of IPV was ascertained at study enrollment and defined as reporting ever experiencing physical or sexual IPV. Those reporting IPV in the month before enrollment were excluded. We tested whether history of IPV modified intervention effectiveness and risk of relationship dissolution using population-averaged Poisson and log-binomial generalized estimating equation models. Exploratory analyses investigated associations between history of IPV and events that occurred after HIV diagnosis using log-binomial generalized estimating equation models. RESULTS: The study enrolled 1119 index participants and 1286 partners. Among index participants, 81 (7%) had history of IPV. History of IPV did not modify APS effectiveness in testing, newly diagnosing, or linking partners to care. History of IPV did not modify the association between receiving immediate APS and relationship dissolution during the study. CONCLUSIONS: Among participants who had not experienced IPV in the last month but had experienced IPV in their lifetimes, our results suggest that APS is an effective and safe partner notification strategy in Kenya. As APS is scaled up in different contexts, these data support including those reporting past IPV and closely monitoring adverse events.

Assisted partner services for HIV in Kenya: a cluster randomised controlled trial.

BACKGROUND: Assisted partner services for index patients with HIV infections involves elicitation of information about sex partners and contacting them to ensure that they test for HIV and link to care. Assisted partner services are not widely available in Africa. We aimed to establish whether or not assisted partner services increase HIV testing, diagnoses, and linkage to care among sex partners of people with HIV infections in Kenya. METHODS: In this cluster randomised controlled trial, we recruited non-pregnant adults aged at least 18 years with newly or recently diagnosed HIV without a recent history of intimate partner violence who had not yet or had only recently linked to HIV care from 18 HIV testing services clinics in Kenya. Consenting sites in Kenya were randomly assigned (1:1) by the study statistician (restricted randomisation; balanced distribution in terms of county and proximity to a city) to immediate versus delayed assisted partner services. Primary outcomes were the number of partners tested for HIV, the number who tested HIV positive, and the number enrolled in HIV care, in those who were interviewed at 6 week follow-up. Participants within each cluster were masked to treatment allocation because participants within each cluster received the same intervention. This trial is registered with ClinicalTrials.gov, number NCT01616420. FINDINGS: Between Aug 12, 2013, and Aug 31, 2015, we randomly allocated 18 clusters to immediate and delayed HIV assisted partner services (nine in each group), enrolling 1305 participants: 625 (48%) in the immediate group and 680 (52%) in the delayed group. 6 weeks after enrolment of index patients, 392 (67%) of 586 partners had tested for HIV in the immediate group and 85 (13%) of 680 had tested in the delayed group (incidence rate ratio 4·8, 95% CI 3·7-6·4). 136 (23%) partners had new HIV diagnoses in the immediate group compared with 28 (4%) in the delayed group (5·0, 3·2-7·9) and 88 (15%) versus 19 (3%) were newly enrolled in care (4·4, 2·6-7·4). Assisted partner services did not increase intimate partner violence (one intimate partner violence event related to partner notification or study procedures occurred in each group). INTERPRETATION: Assisted partner services are safe and increase HIV testing and case-finding; implementation at the population level could enhance linkage to care and antiretroviral therapy initiation and substantially decrease HIV transmission. FUNDING: National Institutes of Health.

Understanding Barriers to Scaling Up HIV-Assisted Partner Services in Kenya.

Assisted partner services (APS) are more effective than passive referral in identifying new cases of HIV in many settings. Understanding the barriers to the uptake of APS in sub-Saharan Africa is important before its scale up. In this qualitative study, we explored client, community, and healthcare worker barriers to APS within a cluster randomized trial of APS in Kenya. We conducted 20 in-depth interviews with clients who declined enrollment in the APS study and 9 focus group discussions with health advisors, HIV testing and counseling (HTC) counselors, and the general HTC client population. Two analysts coded the data using an open coding approach and identified major themes and subthemes. Many participants reported needing more time to process an HIV-positive result before providing partner information. Lack of trust in the HTC counselor led many to fear a breach of confidentiality, which exacerbated the fears of stigma in the community and relationship conflicts. The type of relationship affected the decision to provide partner information, and the lack of understanding of APS at the community level contributed to the discomfort in enrolling in the study. Establishing trust between the client and HTC counselor may increase uptake of APS in Kenya. A client's decision to provide partner information may depend on the type of relationship he or she is in, and alternative methods of disclosure may need to be offered to accommodate different contexts. Spreading awareness about APS in the community may make clients more comfortable providing partner information.

Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial.

BACKGROUND: HIV case-finding and linkage to care are critical for control of HIV transmission. In Kenya, >50% of seropositive individuals are unaware of their status. Assisted partner notification is a public health strategy that provides HIV testing to individuals with sexual exposure to HIV and are at risk of infection and disease. This parallel, cluster-randomized controlled trial will evaluate the effectiveness, cost-effectiveness, and feasibility of implementing HIV assisted partner notification services at HIV testing sites (clusters) in Kenya. METHODS/DESIGN: Eighteen sites were selected among health facilities in Kenya with well-established, high-volume HIV testing programs, to reflect diverse communities and health-care settings. Restricted randomization was used to balance site characteristics between study arms (n = 9 per arm). Sixty individuals testing HIV positive ('index partners') will be enrolled per site (inclusion criteria: ≥18 years, positive HIV test at a study site, willing to disclose sexual partners, and never enrolled for HIV care; exclusion criteria: pregnancy or high risk of intimate partner violence). Index partners provide names and contact information for all sexual partners in the past 3 years. At intervention sites, study staff immediately contact sexual partners to notify them of exposure, offer HIV testing, and link to care if HIV seropositive. At control sites, passive partner referral is performed according to national guidelines, and assisted partner notification is delayed by 6 weeks. Primary outcomes, assessed 6 weeks after index partner enrollment and analyzed at the cluster level, are the number of partners accepting HIV testing and number of HIV infections diagnosed and linked to care per index partner. Secondary outcomes are the incremental cost-effectiveness of partner notification and the costs of identifying >1 partner per index case. Participants are closely monitored for adverse outcomes, particularly intimate partner violence. The study is unblinded due to practical limitations. DISCUSSION: This rigorously designed trial will inform policy decisions regarding implementation of HIV partner notification services in Kenya, with possible application to other parts of sub-Saharan Africa. Examination of effectiveness and cost-effectiveness in diverse settings will enable targeted application and define best practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT01616420 .