Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi.

BACKGROUND: Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining "assisting" health care workers' experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility. METHODS: In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers' experiences counseling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team. RESULTS: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers. CONCLUSIONS: Maximizing assisted ICT's potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT. TRIAL REGISTRATION: NCT05343390. Date of registration: April 25, 2022.

Does a blended learning implementation package enhance HIV index case testing in Malawi? A protocol for a cluster randomised controlled trial.

INTRODUCTION: Index case testing (ICT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention services. In Malawi, delivery of ICT has faced challenges due to limited technical capacity of healthcare workers (HCWs) and clinical coordination. Digitisation of training and quality improvement processes presents an opportunity to address these challenges. We developed an implementation package that combines digital and face-to-face modalities (blended learning) to strengthen HCWs ICT skills and enhance quality improvement mechanisms. This cluster randomised controlled trial will assess the impact of the blended learning implementation package compared with the standard of care (SOC) on implementation, effectiveness and cost-effectiveness outcomes. METHODS AND ANALYSIS: The study was conducted in 33 clusters in Machinga and Balaka districts, in Southern Malawi from November 2021 to November 2023. Clusters are randomised in a 2:1 ratio to the SOC versus blended learning implementation package. The SOC is composed of: brief face-to-face HCW ICT training and routine face-to-face facility mentorship for HCWs. The blended learning implementation package consists of blended teaching, role-modelling, practising, and providing feedback, and blended quality improvement processes. The primary implementation outcome is HCW fidelity to ICT over 1 year of follow-up. Primary service uptake outcomes include (a) index clients who participate in ICT, (b) contacts elicited, (c) HIV self-test kits provided for secondary distribution, (d) contacts tested and (e) contacts identified as HIV-positive. Service uptake analyses will use a negative binomial mixed-effects model to account for repeated measures within each cluster. Cost-effectiveness will be assessed through incremental cost-effectiveness ratios examining the incremental cost of each person tested. ETHICS AND DISSEMINATION: The Malawi National Health Science Research Committee, the University of North Carolina and the Baylor College of Medicine Institutional Review Boards approved the trial. Study findings will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT05343390.

Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi.

Background: Assisted index case testing, in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase PLHIV status awareness. Promising evidence for the approach has led to several attempts to scale assisted index case testing throughout eastern and southern Africa in recent years. However, despite effective implementation being at the heart of any assisted index case testing strategy, there is limited implementation science research from the perspective of the HCWs who are doing the "assisting". This study examines the feasibility of assisted index case testing from the perspective of health care workers implementing the approach in Malawi. Methods: In-depth interviews were conducted with 26 lay health care workers delivering assisted index case testing in Malawian health facilities. Interviews explored health care workers' experiences counselling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted index case testing. Analysis included multiple rounds of coding and iteration with the data collection team. Results: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, logistical obstacles to tracing, and challenges of discussing sexual behavior with clients. Participants also reported several health care worker characteristics that facilitate feasibility: robust understanding of assisted index case testing's rationale and knowledge of procedures, strong interpersonal skills, positive attitudes towards clients, and sense of purpose in their work. Conclusions: Findings demonstrate that maximizing assisted index case testing's potential to increase HIV status awareness requires adequately equipping health care workers with appropriate knowledge, skills, and support to address and overcome the many feasibility challenges that they face in implementation. Trial Registration Number: NCT05343390 Date of registration: April 25, 2022.

Intervention Fidelity to VITAL Start (Video Intervention to Inspire Treatment Adherence for Life) in a Randomized Controlled Trial Among Women Living With HIV in Malawi.

BACKGROUND: Intervention effectiveness in a randomized controlled trial is attributed to intervention fidelity. Measuring fidelity has increasing significance to intervention research and validity. The purpose of this article is to describe a systematic assessment of intervention fidelity for VITAL Start (Video intervention to Inspire Treatment Adherence for Life)-a 27-minute video-based intervention designed to improve antiretroviral therapy adherence among pregnant and breastfeeding women. METHOD: Research Assistants (RAs) delivered VITAL Start to participants after enrolment. The VITAL Start intervention had three components: a pre-video orientation, video viewing, and post-video counseling. Fidelity assessments using checklists comprised self (RA assessment) and observer (Research Officers, also known as ROs) assessment. Four fidelity domains (adherence, dose, quality of delivery, and participant responsiveness) were evaluated. Score scale ranges were 0 to 29 adherence, 0 to 3 dose, 0 to 48 quality of delivery and 0 to 8 participant responsiveness. Fidelity scores were calculated. Descriptive statistics summarizing the scores were performed. RESULTS: In total, eight RAs delivered 379 VITAL Start sessions to 379 participants. Four ROs observed and assessed 43 (11%) intervention sessions. The mean scores were 28 (SD = 1.3) for adherence, 3 (SD = 0) for dose, 40 (SD = 8.6) for quality of delivery, and 10.4 (SD = 1.3) for participant responsiveness. CONCLUSION: Overall, the RAs successfully delivered the VITAL Start intervention with high fidelity. Intervention fidelity monitoring should be an important element of randomized control trial design of specific interventions to ensure having reliable study results.

The prevalence, incidence, and recurrence of intimate partner violence and its association with adverse childhood experiences among pregnant and breastfeeding women living with HIV in Malawi.

Background: Intimate partner violence (IPV) is associated with suboptimal HIV treatment outcomes, but its distribution and risk factors among certain subpopulations of people living with HIV in resource-limited settings are not well known. We examined the prevalence, incidence, and recurrence of IPV and its association with adverse childhood experiences (ACEs) among pregnant/breastfeeding women living with HIV in Malawi. Methods: This study used longitudinal data for 455 pregnant women living with HIV continuously enrolled in the VITAL Start trial. IPV was assessed at baseline and months 1, 6, and 12 using the widely validated WHO IPV survey. Forms of IPV assessed were physical IPV, emotional IPV, and sexual IPV measured as prevalence, incidence, and recurrence. ACE histories were assessed using WHO's ACE International Questionnaire (ACE-IQ) tool. Logistic and log-binomial regressions were used in multivariable analyses that controlled for factors such as depression and alcohol use. Results: Participants' mean age was 27.6 ± 5.7 years. Forty-three percent (43%) reported IPV prevalence, 13% reported IPV incidence, and another 13% reported IPV recurrence, with emotional IPV being the most commonly reported IPV type. Over 96% reported experiencing ⩾1 ACE. In regression analysis, cumulative ACE scores were significantly associated with IPV prevalence and IPV recurrence and in both cases, the magnitude of association was greatest for sexual IPV compared with physical IPV and emotional IPV. ACE scores were not significantly associated with IPV incidence. Conclusions: IPV is highly prevalent among pregnant women living with HIV and continues to occur throughout the pregnancy and postpartum period; its graded relationship with ACEs is a concern in resource-limited settings where HIV/AIDS remains a public health concern. Strategies aimed to address the needs of pregnant/breastfeeding women living with HIV may benefit from the regular screening of this population for IPV and ACE, including in antenatal care clinics.

Development of a Blended Learning Approach to Delivering HIV-Assisted Contact Tracing in Malawi: Applied Theory and Formative Research.

BACKGROUND: Despite progress toward the Joint United Nations Programme on HIV/AIDS "95-95-95" targets (95% of HIV-positive persons tested, 95% of tested persons on treatment, and 95% of treated persons virally suppressed), a gap remains in achieving the first 95% target. Assisted contact tracing (ACT), in which health workers support HIV-positive index clients to recruit their contacts (sexual partners and children) for HIV testing, efficiently identifies HIV-positive persons in need of treatment. Although many countries, including Malawi, began implementing ACT, testing outcomes in routine settings have been worse than those in trial settings. OBJECTIVE: The aim of this paper is to use formative research and frameworks to develop and digitize an implementation package to bridge the gap between ACT research and practice. METHODS: Semistructured qualitative research was conducted in 2019 in Malawi with key informants. Barriers and facilitators to intervention delivery were identified using the Consolidated Framework for Implementation Research. Approaches to digitization were examined using human-centered design principles. RESULTS: Limited clinic coordination and health worker capacity to address the complexities of ACT were identified as barriers. Ongoing individual training consisting of learning, observing, practicing, and receiving feedback, as well as group problem-solving were identified as facilitators. Important features of digitization included (1) culturally relevant visual content, (2) capability of offline use, and (3) simple designs and basic editing to keep costs low. CONCLUSIONS: Formative research and frameworks played a key role in designing and digitizing an implementation package for ACT delivery in a low-income setting such as Malawi.

Pilot-Testing a Blended Learning Package for Health Care Workers to Improve Index Testing Services in Southern Malawi: An Implementation Science Study.

BACKGROUND: HIV index testing, an intervention in which HIV-positive "indexes" (persons diagnosed with HIV) are supported to recruit their "contacts" (sexual partners and children) efficiently identifies HIV-infected persons in need of treatment and HIV-uninfected persons in need of prevention. However, index testing implementation in sub-Saharan African health care settings has been suboptimal. The objective of this study was to develop and pilot test a blended learning capacity-building package to improve index testing implementation in Malawi. METHODS: In 2019, a blended learning package combining digital and face-to-face training modalities was field tested at 6 health facilities in Mulanje, Malawi using a pre-/post- type II hybrid design with implementation and effectiveness outcomes. Health care worker (HCW) fidelity to the intervention was assessed via observed encounters before and after the training. Preliminary effectiveness was examined by comparing index testing program indicators in the 2 months before and 4 months after the training. Indicators included the mean number of indexes screened, contacts elicited, and contacts who received HIV testing per facility per month. RESULTS: On a 30-point scale, HCW fidelity to index testing protocols improved from 6.0 pre- to 25.5 post-package implementation (P = 0.002). Index testing effectiveness indicators also increased: indexes screened (pre = 63, post = 101, P < 0.001); contacts elicited (pre = 75, post = 131, P < 0.001); and contacts who received HIV testing (pre = 27, post = 41, P = 0.014). CONCLUSIONS: The blended learning package improved fidelity to index testing protocols and preliminary effectiveness outcomes. This package has the potential to enhance implementation of HIV index testing approaches, a necessary step for ending the HIV epidemic.

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi.

BACKGROUND: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. METHODS: This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses. DISCUSSION: This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.

Enhancing an HIV index case testing passive referral model through a behavioural skills-building training for healthcare providers: a pre-/post-assessment in Mangochi District, Malawi.

INTRODUCTION: Although knowledge of HIV positivity is a necessary step towards engagement in HIV care, more than one quarter of HIV-positive Malawians remain unaware of their HIV status. Testing the sexual partners, guardians and children of HIV-positive persons (index case finding or ICF) is a promising way of identifying HIV-positive persons unaware of their HIV status. ICF can be passive where the HIV-positive individual (index) invites a partner (or contact) for HIV testing or active where a health provider assists the index with partner notification and offers HIV testing to the partner. Strategies to improve passive ICF have not been thoroughly studied. We describe the impact of a behavioural skills-building training to enhance healthcare workers' (HCWs) implementation of Malawi's passive ICF programme. METHODS: In June 2017, HCWs from 36 health facilities in Mangochi were oriented to Malawi's ICF programme and began implementation. In February and April 2018, a total of 573 HCWs from these facilities received further training from the Tingathe Programme. The training focused on eliciting more untested sexual contacts from indexes and better equipping indexes on issuing "family referral slips" to contacts. Monthly programmatic data were abstracted from clinical registers from October 2017 to July 2018. Monthly programmatic indicators were collected from the Index Case Testing Register and the HIV Counselling and Testing Register and were entered into a data set with one record per facility per month. T-tests were used to compare the means of these indicators. RESULTS: During the ten-month study period, there were 200 facility-months observed before and 124 facility-months observed after training. The mean number of indexes identified per facility-month remained stable after training (pre = 18.9, post = 21.2, p = 0.74), but the mean number of sexual partners listed per facility-month (pre = 6.3, post = 10.6, p < 0.001) increased. The mean number of contacts who received HIV testing (pre = 11.1, post = 24.8, p < 0.001) and the mean number of HIV-positive contacts identified per facility-month (pre = 1.3, post = 2.3, p < 0.001) also increased. CONCLUSIONS: A brief behavioural skills-building training impacted a range of meaningful outcomes, including identification of HIV-positive individuals in a passive ICF programme. Such approaches could facilitate the identification of HIV-positive persons unaware of their HIV status, a necessary step for engagement in HIV care.