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.

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.

The relationship between adverse childhood experiences and common mental disorders among pregnant women living with HIV in Malawi.

INTRODUCTION: Adverse childhood experiences (ACEs) have been linked to common mental disorders (CMDs) such as anxiety and depressive thoughts. We examined the prevalence of ACEs and their association with CMDs among pregnant women living with HIV (PWLHIV) in Malawi-an HIV endemic resource-limited setting. METHODS: This is a cross-sectional study of 798 PWLHIV enrolled in the VITAL Start trial in Malawi (10/2018 to 06/2021) (NCT03654898). ACE histories were assessed using WHO's Adverse Childhood Experiences International Questionnaire (ACE-IQ) tool. Depressive symptoms (somatic complaints, reduced vital energy, anxiety, and depressive thoughts) were assessed using WHO's Self Reporting Questionnaire 20-Item (SRQ-20) tool. Log-binomial regressions were used to examine the association between cumulative ACEs and each depressive symptom, as well as identify ACEs driving this association. RESULTS: The mean age of our sample was 27.5 years. Over 95 % reported having experienced ≥1 ACE. On average, each participant reported four ACEs; 11 % reported sexual abuse. About 52 % and 44 % reported anxiety and depressive thoughts, respectively. In regressions, cumulative ACE scores were significantly associated with depressive symptoms-even after adjusting for multiple testing. This association was primarily driven by reports of sexual abuse. LIMITATIONS: Data on maternal ACEs were self-reported and could suffer from measurement error because of recall bias. CONCLUSIONS: ACEs are widespread and have a graded relationship with depressive symptoms in motherhood. Sexual abuse was found to be a primary driver of this association. Earlier recognition of ACEs and provision of trauma-informed interventions to improve care in PWLHIV may reduce negative mental health sequelae.

Video-Based Intervention for Improving Maternal Retention and Adherence to HIV Treatment: Patient Perspectives and Experiences.

VITAL Start is a video-based intervention aimed to improve maternal retention in HIV care and adherence to antiretroviral therapy (ART) in Malawi. We explored the experiences of pregnant women living with HIV (PWLHIV) not yet on ART who received VITAL Start before ART initiation to assess the intervention's acceptability, feasibility, fidelity of delivery, and perceived impact. Between February and September 2019, we conducted semi-structured interviews with a convenience sample of 34 PWLHIV within one month of receiving VITAL Start. The participants reported that VITAL Start was acceptable and feasible and had good fidelity of delivery. They also reported that the video had a positive impact on their lives, encouraging them to disclose their HIV status to their sexual partners who, in turn, supported them to adhere to ART. The participants suggested using a similar intervention to provide health-related education/counseling to people with long term conditions. Our findings suggest that video-based interventions may be an acceptable, feasible approach to optimizing ART retention and adherence amongst PWLHIV, and they can be delivered with high fidelity. Further exploration of the utility of low cost, scalable, video-based interventions to address health counseling gaps in sub-Saharan Africa is warranted.

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.

VITAL Start: Video-Based Intervention to Inspire Treatment Adherence for Life-Pilot of a Novel Video-Based Approach to HIV Counseling for Pregnant Women Living with HIV.

We developed and piloted a video-based intervention targeting HIV-positive pregnant women to optimize antiretroviral therapy (ART) retention and adherence by providing a VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) before ART. VITAL Start (VS) was grounded in behavior-determinant models and developed through an iterative multi-stakeholder process. Of 306 pregnant women eligible for ART, 160 were randomized to standard of care (SOC), 146 to VS and followed for one-month. Of those assigned to VS, 100% completed video-viewing; 96.5% reported they would recommend VS. Of 11 health workers interviewed, 82% preferred VS over SOC; 91% found VS more time-efficient. Compared to SOC, VS group had greater change in HIV/ART knowledge (p < 0.01), trend towards being more likely to start ART (p = 0.07), and better self-reported adherence (p = 0.02). There were no significant group differences in 1-month retention and pharmacy pill count. VITAL Start was highly acceptable, feasible, with promising benefits to ART adherence.