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.

Economic costs and cost-effectiveness of conditional cash transfers for the uptake of services for the prevention of vertical HIV transmissions in a resource-limited setting.

BACKGROUND: Prevention of mother-to-child transmission (PMTCT) is critical for halting the HIV epidemic. However, innovative approaches to improve PMTCT uptake may be resource-intensive. We examined the economic costs and cost-effectiveness of conditional cash transfers (CCTs) for the uptake of PMTCT services in the Democratic Republic of Congo. METHODS: We leveraged data from a randomized controlled trial of CCTs (n = 216) versus standard PMTCT care alone (standard of care (SOC), n = 217). Economic cost data came from multiple sources, with costs analyzed from the societal perspective and reported in 2016 international dollars (I$). Effectiveness outcomes included PMTCT uptake (i.e., accepting all PMTCT visits and services) and retention (i.e., in HIV care at six weeks post-partum). Generalized estimating equations estimated effectiveness (relative risk) and incremental costs, with incremental effectiveness reported as the number of women needing CCTs for an additional PMTCT uptake or retention. We evaluated the cost-effectiveness of the CCTs at various levels of willingness-to-pay and assessed uncertainty using deterministic sensitivity analysis and cost-effectiveness acceptability curves. RESULTS: Mean costs per participant were I$516 (CCTs) and I$431 (SOC), representing an incremental cost of I$85 (95% CI: 59, 111). PMTCT uptake was more likely for CCTs vs SOC (68% vs 53%, p < 0.05), with seven women needing CCTs for each additional PMTCT service uptake; twelve women needed CCTs for an additional PMTCT retention. The incremental cost-effectiveness of CCTs vs SOC was I$595 (95% CI: I$550, I$638) for PMTCT uptake and I$1028 (95% CI: I$931, I$1125) for PMTCT retention. CCTs would be an efficient use of resources if society's willingness-to-pay for an additional woman who takes up PMTCT services is at least I$640. In the worst-case scenario, the findings remained relatively robust. CONCLUSIONS: Given the relatively low cost of the CCTs, policies supporting CCTs may decrease onward HIV transmission and expedite progress toward ending the epidemic.

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.

The effects of community-based distribution of family planning services on contraceptive use: The case of a national scale-up in Malawi.

RATIONALE: Although many sub-Saharan African countries have scaled-up pilot projects of community-based distribution (CBD) of family planning services, the effects of the scaled-up CBDs on contraceptive use remain unclear. OBJECTIVE: We leveraged a national scale-up of Malawi's Learning and Innovation Population and Family Planning pilot to evaluate the effects of a scale-up of CBDs on contraceptive use. We also investigated whether education and income, two important determinants of contraceptive use behaviors, moderate the effects of the scaled-up CBDs. METHOD: We used the 2000/2004 and 2010/2016 Malawi Demographic and Health Surveys (N = 57,978) and difference-in-differences analyses to estimate the effects of the 2005 national scale-up of CBDs on modern contraceptive use. We used rural and urban communities as the intervention and comparison groups because the national CBDs were implemented only in rural communities. Contraceptive use is defined as the current use of any modern contraceptive method (e.g., pills) and was modelled using multilevel logistic regression. RESULTS: Prior to the implementation of the national scale CBDs (2000/2004), the probability of using contraceptives was 21.5% in rural communities and 26.3% in urban communities. After the scale-up (2010/2016), the probability of using contraceptives increased in both rural and urban communities but was greater in rural communities (44.9% vs. 42.9%). The effect attributable to the national scale CBDs was 6.8 percentage points (95% CI [3.3, 9.7]). The effects of the national CBDs were greater among uneducated and low-income women. CONCLUSIONS: These findings suggest that national CBDs increase overall contraceptive use, particularly in rural communities, and that poor and uneducated women benefit more from family planning interventions that reduce communication and financial barriers.

Suboptimal geographic accessibility to comprehensive HIV care in the US: regional and urban-rural differences.

Achieving US state and municipal benchmarks to end the HIV epidemic and promote health equity requires access to comprehensive HIV care. However, this care may not be geographically accessible for all people living with HIV (PLHIV). We estimated county-level drive time and suboptimal geographic accessibility to HIV care across the contiguous US, assessing regional and urban-rural differences. We integrated publicly available data from four federal databases to identify and geocode sites providing comprehensive HIV care in 2015, defined as the co-located provision of core HIV medical care and support services. Leveraging street network, US Census and HIV surveillance data (2014), we used geographic analysis to estimate the fastest one-way drive time between the population-weighted county centroid and the nearest site providing HIV care for counties reporting at least five diagnosed HIV cases. We summarized HIV care sites, county-level drive time, population-weighted drive time and suboptimal geographic accessibility to HIV care, by US region and county rurality (2013). Geographic accessibility to HIV care was suboptimal if drive time was >30 min, a common threshold for primary care accessibility in the general US population. Tests of statistical significance were not performed, since the analysis is population-based. We identified 671 HIV care sites across the US, with 95% in urban counties. Nationwide, the median county-level drive time to HIV care is 69 min (interquartile range (IQR) 66 min). The median county-level drive time to HIV care for rural counties (90 min, IQR 61) is over twice that of urban counties (40 min, IQR 48), with the greatest urban-rural differences in the West. Nationally, population-weighted drive time, an approximation of individual-level drive time, is over five times longer in rural counties than in urban counties. Geographic access to HIV care is suboptimal for over 170,000 people diagnosed with HIV (19%), with over half of these individuals from the South and disproportionately the rural South. Nationally, approximately 80,000 (9%) drive over an hour to receive HIV care. Suboptimal geographic accessibility to HIV care is an important structural barrier in the US, particularly for rural residents living with HIV in the South and West. Targeted policies and interventions to address this challenge should become a priority.

Structural barriers to comprehensive, coordinated HIV care: geographic accessibility in the US South.

Structural barriers to HIV care are particularly challenging in the US South, which has higher HIV diagnosis rates, poverty, uninsurance, HIV stigma, and rurality, and fewer comprehensive public health programs versus other US regions. Focusing on one structural barrier, we examined geographic accessibility to comprehensive, coordinated HIV care (HIVCCC) in the US South. We integrated publicly available data to study travel time to HIVCCC in 16 Southern states and District of Columbia. We geocoded HIVCCC service locations and estimated drive time between the population-weighted county centroid and closest HIVCCC facility. We evaluated drive time in aggregate, and by county-level HIV prevalence quintile, urbanicity, and race/ethnicity. Optimal drive time was ≤30 min, a common primary care accessibility threshold. We identified 228 service locations providing HIVCCC across 1422 Southern counties, with median drive time to care of 70 min (IQR 64 min). For 368 counties in the top HIV prevalence quintile, median drive time is 50 min (IQR 61 min), exceeding 60 min in over one-third of these counties. Among counties in the top HIV prevalence quintile, drive time to care is six-folder higher for rural versus super-urban counties. Counties in the top HIV prevalence quintiles for non-Hispanic Blacks and for Hispanics have >50% longer drive time to care versus for non-Hispanic Whites. Including another potential care source-publicly-funded health centers serving low-income populations-could double the number of high-HIV burden counties with drive time ≤30 min, representing nearly 35,000 additional people living with HIV with accessible HIVCCC. Geographic accessibility to HIVCCC is inadequate in the US South, even in high HIV burden areas, and geographic and racial/ethnic disparities exist. Structural factors, such as geographic accessibility to care, may drive disparities in health outcomes. Further research on programmatic policies, and evidence-based alternative HIV care delivery models improving access to care, is critical.