Effects of M-DEPTH Model of Depression Care on Maternal HIV Viral Suppression and Adherence to the PMTCT Care Continuum Among HIV-Infected Pregnant Women in Uganda: Results from a Cluster Randomized Controlled Trial at Pregnancy Completion.

Perinatal depression has been shown to impede adherence to antiretroviral therapy (ART) and the prevention of mother-to-child transmission (PMTCT) care continuum; therefore, treating perinatal depression may result in increased viral suppression and PMTCT adherence. We examined the effects of the M-DEPTH (Maternal Depression Treatment in HIV) depression care model (including antidepressants and individual Problem Solving Therapy) on depression, maternal viral suppression and adherence to PMTCT care processes in an ongoing cluster-randomized controlled trial of 391 HIV-infected pregnant women (200 usual care; 191 intervention) with at least mild depressive symptoms enrolled across 8 antenatal care clinics in Uganda. At baseline, 68.3% had clinical depression and 41.7% had detectable HIV viral load. Adjusted repeated-measures multivariable regression models found that the intervention group was nearly 80% less likely to be clinically depressed [Adjusted OR (95% CI) 0.22 (0.05, 0.89)] at the 2-month post-pregnancy assessment, compared to the control group. However, the intervention and control groups did not differ meaningfully on maternal viral suppression, ART adherence, and other PMTCT care processes and outcomes. In this sample of women who were mostly virally suppressed and ART adherent at baseline, the depression care model had a strong effect on depression alleviation, but no downstream effects on viral suppression or other PMTCT care processes.Trial Registration NIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov).

The yield of HIV testing during pregnancy and postnatal period, Uganda, 2015-2018: analysis of surveillance data.

BACKGROUND: Uganda has registered a reduction in new HIV infections among children in recent years. However, mother-to-child transmission of HIV still occurs, especially among pregnant women who present late. To eliminate this transmission, all HIV-positive pregnant women should be identified during antenatal HIV testing. We described women newly identified HIV-positive during pregnancy and postnatal period 2015-2018. METHODS: We extracted surveillance data for women identified as HIV-positive during pregnancy and the postnatal period reported through the Health Management Information System from 2015-2018. We calculated proportions newly positive at antenatal, labor, and postnatal periods nationally and at district levels. We disaggregated data into 'tested early' (during antenatal care) and 'tested late' (during labor or postnatal period) and calculated the proportion positive. We evaluated trends in these parameters at national and district levels. RESULTS: Overall, 8,485,854 mothers were tested for HIV during this period. Of these, 2.4% tested HIV-positive for the first time. While the total number of mothers tested increased from 1,327,022 in 2015 to 2,514,212 in 2018, the proportion testing HIV-positive decreased from 3.0% in 2015 to 1.7% in 2018 (43% decline over the study period, p < 0.001). Of 6,781,047 tested early, 2.2% tested HIV-positive. The proportion positive among those tested early dropped from 2.5% in 2015 to 1.7% in 2018. Of 1,704,807 tested late, 3.2% tested HIV-positive. The proportion positive among those tested late dropped from 5.2% in 2015 to 1.6% in 2018. At the district level, Kalangala District had the highest proportion testing positive at 13% (909/11,312) in 2015; this dropped to 5.2% (169/3278) in 2018. CONCLUSION: The proportion of women newly testing HIV-positive during pregnancy and postnatal declined significantly during 2015-2018. A higher proportion of mothers who tested late vs early were HIV-positive. Failure to identify HIV early represents an increased risk of transmission. Ministry of Health should strengthen Elimination of Mother to Child Transmission (eMTCT) services to sustain this decrease through targeted interventions for poorly-performing districts. It should strengthen community-based health education on antenatal care and HIV testing and enhance the implementation of other primary prevention strategies targeting adolescents and young women.

Low proportion of women who came knowing their HIV status at first antenatal care visit, Uganda, 2012-2016: a descriptive analysis of surveillance data.

BACKGROUND: HIV testing is the cornerstone for HIV care and support services, including Prevention of Mother to Child Transmission of HIV (PMTCT). Knowledge of HIV status is associated with better reproductive health choices and outcomes for the infant's HIV status. We analyzed trends in known current HIV status among pregnant women attending the first antenatal care (ANC) visit in Uganda, 2012-2016. METHODS: We conducted secondary data analysis using District Health Information Software2 data on all pregnant women who came for ANC visit during 2012-2016. Women who brought documented HIV negative test result within the previous 4 weeks at the first ANC visit or an HIV positive test result and/or own HIV care card were considered as knowing their HIV status. We calculated proportions of women with known current HIV status at first ANC visit, and described linear trends both nationally and regionally. We tested statistical significance of the trend using modified Poisson regression with generalized linear models. For known HIV positive status, we only analyzed data for years 2015-2016 because this is when this data became available. RESULTS: There was no significant difference in the number of women that attended first ANC visits over years 2012-2016. The proportion of women that came with known HIV status increased from 4.4% in 2012 to 6.9% in 2016 and this increase was statistically significant (p < 0.001). Most regions had an increase in trend except the West Nile and Mid-Eastern (p < 0.001). The proportion of women that came knowing their HIV positive status at first ANC visit was slightly higher than that of women that were newly tested HIV positive at first ANC visit in 2015 and 2016. CONCLUSION: Although the gap in women that come at first ANC visit without knowing their HIV positive status might be reducing, a large proportion of women who were infected with HIV did not know their status before the first ANC visit indicating a major public health gap. We recommend advocacy for early ANC attendance and hence timely HIV testing and innovations to promptly identify HIV positive women of reproductive age so that timely PMTCT interventions can be made.

Multivariate analysis of covariates of adherence among HIV-positive mothers with low viral suppression.

BACKGROUND: As part of efforts to improve the prevention of mother-to-child transmission in Northern Uganda, we explored reasons for poor viral suppression among 122 pregnant and lactating women who were in care, received viral load tests, but had not achieved viral suppression and had more than 1000 copies/mL. Understanding the patient factors associated with low viral suppression was of interest to the Ministry of Health to guide the development of tools and interventions to achieve viral suppression for pregnant and lactating women newly initiating on ART as well as those on ART with unsuppressed viral load. METHODS: A facility-based cross-sectional and mixed methods study design was used, with retrospective medical record review. We assessed 122 HIV-positive mothers with known low viral suppression across 31 health facilities in Northern Uganda. Adjusted odds ratios were used to determine the covariates of adherence among HIV positive mothers using logistic regression. A study among health care providers shed further light on predictors of low viral suppression and a history of low early retention. This study was part of a larger national evaluation of the performance of integrated care services for mothers. RESULTS: Adherence defined as taking antiretroviral medications correctly everyday was low at 67.2%. The covariates of low adherence are: taking other medications in addition to ART, missed appointments in the past 6 months, experienced violence in the past 6 months, and faces obstacles to treatment. Mothers who were experiencing each of these covariates were less likely to adhere to treatment. These covariates were triangulated with perspectives of health providers as covariates of low adherence and included: long distances to health facility, missed appointments, running out of pills, sharing antiretroviral drugs, violence, and social lifestyles such as multiple sexual partners coupled with non-disclosure to partners. Inadequate counseling, stigma, and lack of client identity are the frontline factors accounting for the early loss of mothers from care. CONCLUSIONS: Adherence of 67% was low for reliable viral suppression and accounts for the low viral suppression among HIV-positive mothers studied, in absence of any other factors. This study provided insights into the covariates for low adherence to ART and low viral load suppression; these covariates included taking other medications in addition to ART, missed appointments in the past 6 months, feels like giving up, doesn't have someone with whom to share private concerns, experienced violence in the past 6 months, and faces obstacles to treatment and confirmed by health providers. To improve adherence, we recommend use of a screening tool to identify mothers with any of these covariates so that more intensive adherence support can be provided to these mothers.

Effects of M-DEPTH Model of Depression Care on Maternal Functioning and Infant Developmental Outcomes in the Six Months Post Delivery: Results from a Cluster Randomized Controlled Trial.

Perinatal depression has been shown to have deleterious effects on maternal post-partum functioning, as well as early child development. However, few studies have documented whether depression care helps to mitigate these effects. We examined the effects of the M-DEPTH (Maternal Depression Treatment in HIV) depression care model (including antidepressants and individual Problem Solving Therapy) on maternal functioning and infant development in the first 6 months post-delivery in an ongoing cluster randomized controlled trial of 391 HIV-infected women with at least mild depressive symptoms enrolled across eight antenatal care clinics in Uganda. A subsample of 354 (177 in each of the intervention and control groups) had a live birth delivery and comprised the analytic sample, of whom 69% had clinical depression at enrollment; 70% of women in the intervention group (including 96% of those with clinical depression) received depression treatment. Repeated-measures multivariable regression models found that the intervention group reported better infant care, lower parental burden, and greater perceived adequacy of parental support, compared to the control group. These findings suggest that depression care for pregnant women living with HIV is important not only for maternal mental health, but it also helps women to better manage parenting and care for their infant.

Increasing HIV-Free Survival of Infants: Reorganizing Care Using Quality Improvement for the Optimal Health and Nutrition of HIV-Positive Women and Their Exposed Infants in Uganda.

Reorganizing service delivery to integrate nutrition and infant and young child feeding (IYCF) with prevention of mother-to-child transmission (PMTCT) is important for improving outcomes of HIV-positive mothers and HIV-exposed infants (HEIs). Quality improvement (QI) strategies were implemented at 22 health facilities. The percentage of HIV-positive pregnant women and lactating mothers who received IYCF counseling at each visit improved (45%-100%; mean = 93.1%, standard deviation [SD] = 15.5). Adherence to IYCF practices improved (70%-96%; mean = 92.4%, SD = 8.5). Mother-baby pairs receiving the standard care package improved (0%-100%; mean = 98.6%, SD = 22.6). The HEIs alive at 18 months and infected decreased (mean = 6.2%, SD = 4.8). Statistical significance of change was estimated using Fisher exact test and magnitude of change over time by calculating the odds ratio. For all indicators, improvement was rapid and significant (P < .001), especially in the first 6 months of QI implementation. Using QI to integrate nutrition and ensure consistent and comprehensive PMTCT service delivery improved IYCF adherence and decreased transmission.

Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial.

INTRODUCTION: Over one-third of human immunodeficiency virus (HIV)-infected pregnant women are clinically depressed, increasing the risk of mother-to-child transmission (MTCT) of HIV, as well as negative birth and child development outcomes. This study will evaluate the efficacy and cost-effectiveness of an evidence-based stepped care treatment model for perinatal depression (maternal depression treatment in HIV [M-DEPTH]) to improve adherence to prevention of MTCT care among HIV+ women in Uganda. METHODS: Eight antenatal care (ANC) clinics in Uganda will be randomized to implement either M-DEPTH (n=4) or usual care (n=4) for perinatal depression among 400 pregnant women (n=50 per clinic) between June 2019 and August 2022. At each site, women who screen positive for potential depression will be enrolled and followed for 18 months post-delivery, assessed in 6-month intervals: baseline, within 1 month of child delivery or pregnancy termination, and months 6, 12, and 18 following delivery. Primary outcomes include adherence to the prevention of mother-to-child transmission (PMTCT) care continuum-including maternal antiretroviral therapy and infant antiretrovial prophylaxis, and maternal virologic suppression; while secondary outcomes will include infant HIV status, post-natal maternal and child health outcomes, and depression treatment uptake and response. Repeated-measures multivariable regression analyses will be conducted to compare outcomes between M-DEPTH and usual care, using 2-tailed tests and an alpha cut-off of P <.05. Using a micro-costing approach, the research team will relate costs to outcomes, examining the incremental cost-effectiveness ration (ICER) of M-DEPTH relative to care as usual. DISCUSSION: This cluster randomized controlled trial will be one of the first to compare the effects of an evidence-based depression care model versus usual care on adherence to each step of the PMTCT care continuum. If determined to be efficacious and cost-effective, this study will provide a model for integrating depression care into ANC clinics and promoting adherence to PMTCT. TRIAL REGISTRATION: NIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov).

An early assessment of Uganda's roll-out of Option B+: Service capacity and infant outcomes.

BACKGROUND: Uganda was one of the first countries in sub-Saharan Africa to implement Option B+ as its national strategy for prevention-of-mother-to-child transmission (PMTCT) of HIV, doing so in 2013. We report on two evaluations designed to assess the capacity of the health care system to implement Option B+, and to obtain preliminary information on the maternal-to-child-transmission rate of HIV. METHODS: We performed: 1) a cross-sectional assessment in 2014 of 505 health care facilities (49 district hospitals, 83 Health Center [HC] IVs, and 373 HCIIIs) in 62 of Uganda's 112 districts to evaluate whether services and commodities required for Option B+ were being provided; and 2) a retrospective record review of 283 HIV-exposed infants enrolled in post-natal care in 2013 in the Central Region to evaluate infant outcomes at 18-months of age. RESULTS: Less than 50% of HCIIIs performed routine diagnostics, including syphilis, hemoglobin, and urinalysis testing, required at all ante-natal clinics; almost all facilities performed a baseline CD4 cell count, but only 44.5% of HCIIIs and 60.2% of HCIVs performed follow-up testing. The proportion of facilities monitoring antiretroviral therapy (ART) (47.2-69.4%) and clinic adherence (50.0-67.3%) was low. Many facilities (20.4-45.8%) reported stock-outs of ART and HIV test kits in the prior month. At 18 months, 53.7% of HIV-exposed infants were lost to follow-up (LTFU). Among those retained, 6.5% were HIV infected. CONCLUSION: Significant shortcomings in service provision and high LTFU of HIV-exposed infants are barriers to Uganda's ability to implement Option B+ successfully.