Dataset Information

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

ABSTRACT:

Background

South Africa (SA) has the greatest HIV prevalence in the world, with rates as high as 40% among pregnant women. Depression is a robust predictor of nonadherence to antiretroviral therapy (ART) and engagement in HIV care; perinatal depression may affect upwards of 47% of women in SA. Evidence-based, scalable approaches for depression treatment and ART adherence in this setting are lacking.

Method

Twenty-three pregnant women with HIV (WWH), ages 18-45 and receiving ART, were randomized to a psychosocial depression and adherence intervention or treatment as usual (TAU) to evaluate intervention feasibility, acceptability, and preliminary effect on depressive symptoms and ART adherence. Assessments were conducted pre-, immediately post-, and 3 months post-treatment, and included a qualitative exit interview.

Results

Most (67.6%) eligible individuals enrolled; 71% completed at least 75% of sessions. Compared to TAU, intervention participants had significantly greater improvements in depressive symptoms at post-treatment, β = - 11.1, t(24) = - 3.1, p < 0.005, 95% CI [- 18.41, - 3.83], and 3 months, β = - 13.8, t(24) = - 3.3, p < 0.005, 95% CI [- 22.50, - 5.17]. No significant differences in ART adherence, social support, or stigma were found. Qualitatively, perceived improvements in social support, self-esteem, and problem-solving adherence barriers emerged as key benefits of the intervention; additional sessions were desired.

Conclusion

A combined depression and ART adherence intervention appears feasible and acceptable, and demonstrated preliminary evidence of efficacy in a high-need population. Additional research is needed to confirm efficacy and identify dissemination strategies to optimize the health of WWH and their children.

Trial registration

ClinicalTrials.gov identifier: NCT03069417. Protocol available at https://clinicaltrials.gov/ct2/show/NCT03069417.

SUBMITTER: Psaros C

PROVIDER: S-EPMC9452601 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

Psaros Christina C Stanton Amelia M AM Raggio Greer A GA Mosery Nzwakie N Goodman Georgia R GR Briggs Elsa S ES Williams Marcel M Bangsberg David D Smit Jenni J Safren Steven A SA

International journal of behavioral medicine 20220308 1

<h4>Background</h4>South Africa (SA) has the greatest HIV prevalence in the world, with rates as high as 40% among pregnant women. Depression is a robust predictor of nonadherence to antiretroviral therapy (ART) and engagement in HIV care; perinatal depression may affect upwards of 47% of women in SA. Evidence-based, scalable approaches for depression treatment and ART adherence in this setting are lacking.<h4>Method</h4>Twenty-three pregnant women with HIV (WWH), ages 18-45 and receiving ART, w ...[more]

PMID: 35260947

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Project description:BACKGROUND:We evaluate the impact a multicomponent, behavioural, prevention of mother to child transmission (PMTCT), cluster randomised controlled trial on HIV stigma reduction among perinatal HIV infected women in rural South Africa. METHODS:In a cluster randomised controlled trial, twelve community health centres (CHCs) in Mpumalanga Province, South Africa, were randomised; pregnant women living with HIV enrolled received either: A Standard Care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n =357), or an Enhanced Intervention (EI) condition of SC PMTCT plus the 'Protect Your Family' intervention (EI; 6 CHCs; n =342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions; those in the EI, four antenatal and two postnatal group PMTCT sessions, including stigma reduction, led by trained lay health workers. Maternal PMTCT, HIV knowledge and HIV related stigma were assessed. The impact of the EI was ascertained on stigma reduction (baseline, 12 months postnatally). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention. RESULTS:In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed prenatally at baseline and at 12 months (59.5%) postnatally. Baseline scores of overall HIV related stigma and the four scale factors (personalised stigma, disclosure concerns, negative self-image, and concern public attitudes) decreased at follow-up in the intervention group, while baseline scores of overall stigma and three scale factors (personalised stigma, negative self-image, and concern public attitudes) increased at follow-up in the control group. Using longitudinal analyses, Model 1, which included time-invariant predictors of stigma assessed over the two time periods of baseline and 12 months, increases in stigma from baseline to 12 months were associated with being unemployed, having been diagnosed with HIV before the current pregnancy, and alcohol use. In Model 2, which included time-varying predictors, lower stigma scores were associated with participation in the intervention, greater male partner involvement, and consistent condom use. CONCLUSION:The enhanced PMTCT intervention, including stigma reduction, administered by trained lay health workers had a significant effect on the reduction of HIV related stigma. TRIAL REGISTRATION:clinicaltrials.gov: number NCT02085356.

Project description:BackgroundMaternal knowledge that motivates improvements in critical perinatal health behaviors has the potential to significantly reduce maternal and neonatal mortality. However, evidence-based health information often fails to reach mothers and their partners. mHealth video micro-messages, which disseminate evidence-based perinatal health messages, have the potential to address this gap.MethodsThe study will make use of a mixed method design, using both qualitative and quantitative methods. The study consists of two phases. During Phase 1, qualitative in-depth interviews will be used as part of a human-centered design approach to co-create 10 videos on priority perinatal behaviors. During Phase 2, quantitative methods (a randomized control trial) will be used to test the effectiveness of the videos in improving maternal knowledge and intended behavioral change.DiscussionWe hypothesize that by engaging mothers and their partners through emotive, resonant narratives and visuals, we can facilitate the delivery of evidence-based health messages at the foundation of perinatal health, thereby motivating life-saving improvements in health behaviors during the perinatal period.Trial registrationThis trial has been prospectively registered on the Pan African Clinical Trials Registry (PACTR), with the registration number PACTR202203673222680 . Registration date: 14 March 2022. TRIAL REGISTRATION WHO DATA SET: Registry - Pan African Clinical Trials Registry (PACTR). Date: 14 March 2022. Secondary identification number - grant number: GCCSOAFMNH1. Source of support: Science for Africa Foundation. Primary sponsor - Clinton Health Access Initiative South Africa. Secondary sponsor - Stanford University School of Medicine and Heidelberg University. Contact for public & scientific queries: amandlamamasa@clintonhealthaccess.org ; +27 123,426,911; 1166 Francis Baard St, Hatfield, Pretoria, 0028. Public title - Amandla Mama. Scientific title - Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa. Countries of recruitment - South Africa. Health conditions - antenatal care. Intervention - Amandla Mama mHealth videos, short 2D animated health promotional videos that promote healthy behavior in expectant mothers. Inclusion and exclusion criteria - Expectant mothers and their partners must be 18 years and older. Study type - randomized control trial. Date of first enrollment - 14 March 2021. Sample size - plan to enrol 450 participants, participants enrolled 29 participants. Recruitment Status - suspended. Primary outcome - improving knowledge. Secondary outcome - intended behavioral change. Ethics review - Approved on 24 January 2022 by Pharma-Ethics, contact Mrs. Marzelle Haskins, marzelle@pharma-ethics.co.za . Completion date - N/A. Summary results - N/A. IPD sharing statement - yes, through the publication of results in a journal article.

Project description:IntroductionMajor depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task-shared cognitive-behavioural therapy for adherence and depression (CBT-AD) in HIV, delivered by clinic nurses in South Africa.MethodsThis was a two-arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One-hundred-sixty-one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task-shared, nurse-delivered CBT-AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM-D) scores, and weekly adherence via real-time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4-, 8- and 12-month follow-ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time.ResultsAt 4 months, the HAMD scores in the CBT-AD condition improved by an estimated 4.88 points more (CI: -7.86, -1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow-ups, CBT-AD had an estimated 5.63 lower HAMD scores (CI: -7.90, -3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow-ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT-AD. CD4 was not significantly different between groups at 12 months or over time.ConclusionsTask-shared, nurse-delivered, CBT-AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self-care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost-effectiveness are needed to translate findings into clinical practice.Trial registrationClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824.

Project description:BackgroundWith an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care.MethodsNewly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses.ResultsBetween February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001).ConclusionThis study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services.Trial registrationClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Project description:BackgroundAntiretroviral therapy (ART) has potential to eliminate perinatal HIV infections, but adherence to ART in late pregnancy and postpartum is often suboptimal. Intimate partner violence (IPV) may influence non-adherence among perinatal women living with HIV (WWH), but few quantitative studies have examined this over time or explored mechanisms for this association.MethodsWe used secondary data from a parent trial in Johannesburg comprising WWH from the control arm (n=63) and WWH ineligible for the trial (n=133). Trained nurse researchers administered questionnaires at first antenatal visit on past-year psychological, physical, and/or sexual IPV (WHO instrument), socio-demographics (age, food security, education), and perinatal common mental symptoms of depression (Hospital Anxiety and Depression Screener-d); anxiety (HADS-a); post-traumatic stress disorder (PTSD; Harvard Trauma Questionnaire). At endline visit 2-4 months postpartum, nurse researchers assessed self-reported ART adherence using a visual analog scale (with ≥95% considered "good"). We fitted structural equation models (SEM) in MPlus to explore direct and indirect effects of IPV on ART adherence.ResultsOf 196 perinatal WWH, 53.1% reported IPV exposure at baseline. The majority of participants (85.7%) had good perinatal ART adherence. In adjusted models, IPV at baseline was associated with halved odds of good adherence (aOR=0.51, 95%CI=0.20-0.96). IPV was associated with higher adjusted odds of probable depression (aOR=4.64), anxiety (aOR=2.85), and PTSD (aOR=3.42). In SEM, IPV had a direct (standardized coef=-0.22) and indirect effect (coef=-0.05) on ART via common mental disorders. The total effect of IPV on perinatal adherence was of moderate size (coef= -0.27) and the model had good fit (CFI=0.972; TLI=0.969; RMSEA=0.045; SRMR=0.076).ConclusionIPV was longitudinally associated with perinatal ART non-adherence in part due to its relationship with mental health symptomology. Addressing IPV within clinical care has potential to improve perinatal mental health, maternal HIV outcomes, and HIV-free infant survival.

Project description:BackgroundThe aim of the study was to identify trajectories of perinatal depressive symptoms and their predictors among women living in a low-resource setting in South Africa, and who present with a risk of depression during pregnancy.MethodsThis is a secondary analysis of a randomised controlled trial among 384 women living in Khayelitsha, a low income setting in South Africa, recruited at their first antenatal visit if they scored 13 or above on the Edinburgh Postnatal Depression Scale, were at least 18 years of age, less than 29 weeks pregnant and spoke isiXhosa. Participants were followed up at 8 months gestation, 3 and 12 months postpartum. Latent trajectories of depressive symptoms were identified using growth mixture modelling, based on the Hamilton Depression Rating Scale (HDRS). There were no differences in HDRS scores between the control and intervention arms, so all participants were assessed together. Health, social and economic predictors of trajectories were investigated to identify high-risk groups with greater or more chronic depressive symptoms, using univariate logistic regression.ResultsTwo trajectories were identified: antenatal only (91.4%), with moderate to severe symptoms at baseline which later subside; and antenatal and postnatal (8.6%), with severe depressive symptoms during pregnancy and later in the postpartum period, which subside temporarily to moderate levels at 3 months postpartum. Predictors for the antenatal and postnatal trajectory include severe food insecurity, intimate partner violence, lower social support, greater functional impairment, problematic drinking and suicide risk.ConclusionsA small proportion of women who are at risk for depression antenatally remain at risk throughout the perinatal period, and can be differentiated from those who show a natural remission. Identification and referral strategies should be developed with these findings in mind, especially given the limited mental health resources in low-income settings.

Dataset Information

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

Background

Method

Results

Conclusion

Trial registration

Publications

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

Similar Datasets

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