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.

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 .