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.

Comparative Effectiveness of Second-line Antihyperglycemic Agents for Cardiovascular Outcomes: A Large-scale, Multinational, Federated Analysis of the LEGEND-T2DM Study.

Background: SGLT2 inhibitors (SGLT2is) and GLP-1 receptor agonists (GLP1-RAs) reduce major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM). However, their effectiveness relative to each other and other second-line antihyperglycemic agents is unknown, without any major ongoing head-to-head trials. Methods: Across the LEGEND-T2DM network, we included ten federated international data sources, spanning 1992-2021. We identified 1,492,855 patients with T2DM and established cardiovascular disease (CVD) on metformin monotherapy who initiated one of four second-line agents (SGLT2is, GLP1-RAs, dipeptidyl peptidase 4 inhibitor [DPP4is], sulfonylureas [SUs]). We used large-scale propensity score models to conduct an active comparator, target trial emulation for pairwise comparisons. After evaluating empirical equipoise and population generalizability, we fit on-treatment Cox proportional hazard models for 3-point MACE (myocardial infarction, stroke, death) and 4-point MACE (3-point MACE + heart failure hospitalization) risk, and combined hazard ratio (HR) estimates in a random-effects meta-analysis. Findings: Across cohorts, 16·4%, 8·3%, 27·7%, and 47·6% of individuals with T2DM initiated SGLT2is, GLP1-RAs, DPP4is, and SUs, respectively. Over 5·2 million patient-years of follow-up and 489 million patient-days of time at-risk, there were 25,982 3-point MACE and 41,447 4-point MACE events. SGLT2is and GLP1-RAs were associated with a lower risk for 3-point MACE compared with DPP4is (HR 0·89 [95% CI, 0·79-1·00] and 0·83 [0·70-0·98]), and SUs (HR 0·76 [0·65-0·89] and 0·71 [0·59-0·86]). DPP4is were associated with a lower 3-point MACE risk versus SUs (HR 0·87 [0·79-0·95]). The pattern was consistent for 4-point MACE for the comparisons above. There were no significant differences between SGLT2is and GLP1-RAs for 3-point or 4-point MACE (HR 1·06 [0·96-1·17] and 1·05 [0·97-1·13]). Interpretation: In patients with T2DM and established CVD, we found comparable cardiovascular risk reduction with SGLT2is and GLP1-RAs, with both agents more effective than DPP4is, which in turn were more effective than SUs. These findings suggest that the use of GLP1-RAs and SGLT2is should be prioritized as second-line agents in those with established CVD. Funding: National Institutes of Health, United States Department of Veterans Affairs.

Phone-based psychosocial counseling for people living with HIV: Feasibility, acceptability and impact on uptake of psychosocial counseling services in Malawi.

People living with HIV experience psychosocial needs that often are not addressed. We designed an innovative low-resource model of phone-based psychosocial counseling (P-PSC). We describe cohort characteristics, acceptability, feasibility and utilization of P-PSC at health facilities supported by Baylor Foundation Malawi. Staff were virtually oriented at 120 sites concurrently. From facility-based phones, people with new HIV diagnosis, high viral load, treatment interruption or mental health concerns were referred without identifiable personal information to 13 psychosocial counselors via a WhatsApp group. Routine program data were retrospectively analyzed using univariate approaches and regressions with interrupted time series analyses. Clients utilizing P-PSC were 63% female, 25% youth (10-24 y) and 9% children (<10 y). They were referred from all 120 supported health facilities. Main referral reasons included new HIV diagnosis (32%), ART adherence support (32%) and treatment interruption (21%). Counseling was completed for 99% of referrals. Counseling sessions per month per psychosocial counselor increased from 77 before P-PSC to 216 in month 1 (95% CI = 82, 350, p = 0.003). Total encounters increased significantly to 31,642 in year 1 from ~6,000 during the 12 prior months, an over fivefold increase. P-PSC implementation at 120 remote facilities was acceptable and feasible with immediate, increased utilization despite few psychosocial counselors in Malawi.

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.

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.

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.

The HIV diagnostic assistant: early findings from a novel HIV testing cadre in Malawi.

OBJECTIVES: In 2015, Malawi piloted the HIV diagnostic assistant (HDA), a cadre of lay health workers focused primarily on HIV testing services. Our objective is to measure the effect of HDA deployment on country-level HIV testing measures. DESIGN: Interrupted time series analysis of routinely collected data to assess immediate change in absolute numbers and longitudinal changes in trends. METHODS: Data from all HDA sites were divided into two periods: predeployment (October 2013 to June 2015) and postdeployment (July 2015 to December 2017). Monthly rates of several key HIV testing measures were evaluated: HIV testing, including all tests done, new positives, and confirmatory testing. Syphilis testing at antenatal clinic (ANC) and early infant diagnosis were also assessed. FINDINGS: The number of patients tested for HIV per month increased after HDA deployment across all sex, age, and testing subgroups. The number of tests immediately increased by 35 588 (P = 0.031), and the postintervention trend was significantly greater than the preintervention slope (+3442 per month, P = 0.001). Of 7.4 million patients tested for HIV in the postdeployment period, 2.6 million (34%) were attributable to the intervention. The proportion of new positives receiving confirmatory tests increased from 28% preintervention to 98% postintervention (P < 0.0001). Syphilis testing rates at ANC improved, with 98% of all tests attributable to HDA deployment. The number and proportion of infants receiving DNA-PCR testing at 2 months experienced significant trend increases (P < 0.0001). INTERPRETATION: HDA deployment is associated with significant increases in total HIV testing, identification of new positives, confirmatory testing, syphilis testing at ANC, and early infant diagnosis testing.

Family Testing: An Index Case Finding Strategy to Close the Gaps in Pediatric HIV Diagnosis.

Despite significant advances in pediatric HIV treatment, too many children remain undiagnosed and thus without access to lifesaving antiretroviral therapy. It is critical to identify these children and initiate antiretroviral therapy as early as possible. Although the children of HIV-infected adults are at higher risk of infection, few access HIV testing services because of missed opportunities in existing case finding programs. Family testing is an index case finding strategy through which HIV-infected patients are systematically screened to identify family members with unknown HIV status. By specifically targeting a high-risk population, family testing is a pragmatic, high-yield, and efficient approach to identify previously undiagnosed HIV-infected children and link them to care before they become symptomatic. Despite this, incorporation of family testing into national guidelines and implementation of this case finding approach is variable. In this article, we review the evidence base for family testing, describe its challenges, and provide guidance and sample tools for program managers aiming to integrate family testing into existing health systems.