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Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

ABSTRACT: Throughout Africa, Peer Mentors who are women living with HIV (WLH) are supporting pregnant WLH at antenatal and primary healthcare clinics (McColl in BMJ 344:e1590, 2012). We evaluate a program using this intervention strategy at 1.5 months post-birth. In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for their WLH to receive either: standard care (SC), based on national guidelines to prevent mother-to-child transmission (4 clinics; n = 656 WLH); or an enhanced intervention (EI; 4 clinics; n = 544 WLH). The EI consisted of four antenatal and four postnatal small group sessions led by Peer Mentors, in addition to SC. WLH were recruited during pregnancy and 70 % were reassessed at 1.5 months post-birth. EI's effect was ascertained on 16 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall effectiveness. Among EI WLH reassessed, 87 % attended at least one intervention session (mean 4.1, SD 2.0). Significant overall benefits were found in EI compared to SC using the binomial test. However, it is important to note that EI WLH were significantly less likely to adhere to ARV during pregnancy compared to SC. Secondarily, compared to SC, EI WLH were more likely to ask partners to test for HIV, better protected their infants from HIV transmission, and were less likely to have depressed mood and stunted infants. Adherence to clinic intervention groups was low, yet, there were benefits for maternal and infant health at 1.5 months post-birth.

SUBMITTER: Richter L

PROVIDER: S-EPMC4109271 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

Richter Linda L Rotheram-Borus Mary Jane MJ Van Heerden Alastair A Stein Alan A Tomlinson Mark M Harwood Jessica M JM Rochat Tamsen T Van Rooyen Heidi H Comulada W Scott WS Tang Zihling Z

AIDS and behavior 20140401 4

Throughout Africa, Peer Mentors who are women living with HIV (WLH) are supporting pregnant WLH at antenatal and primary healthcare clinics (McColl in BMJ 344:e1590, 2012). We evaluate a program using this intervention strategy at 1.5 months post-birth. In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for their WLH to receive either: standard care (SC), based on national guidelines to prevent mother-to-child transmission (4 clinics; n = 656 W ...[more]

PMID: 24469222

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Project description:BackgroundPerinatal women living with HIV (PWLH) have a greater risk of depression compared to other women; however, there are limited specialized mental health services available to them. We aimed to determine whether a stepped-care intervention facilitated by trained lay providers can improve mental health outcomes postpartum for PWLH.Methods and findingsHealthy Options is a cluster-randomized controlled study conducted in 16 government-managed antenatal care clinics that provided HIV care for pregnant women in urban Tanzania. Recruitment occurred from May 2015 through April 2016, with the final round of data collection completed in October 2017. Participants included a consecutive sample of pregnant women under 30 weeks of gestation, living with HIV and depression, and attending the study clinics. Control sites received enhanced usual care for depression (EUDC). Intervention sites received EUDC plus the Healthy Options intervention, which includes prenatal group sessions of problem-solving therapy (PST) plus cognitive behavioral therapy (CBT) sessions for individuals showing depressive symptoms at 6 weeks postdelivery. We assessed depressive symptoms comparable to major depressive disorder (MDD) using the Patient Health Questionnaire-9 (PHQ-9) with a locally validated cutoff at 9 months and 6 weeks postpartum. The primary time point is 9 months postpartum. We examined differences in outcomes using an intent-to-treat analysis with a complete case approach, meaning those with data at the relevant time point were included in the analysis. We used generalized estimating equations accounting for clustering. Of 818 women screened using the PHQ-9, 742 were determined eligible and enrolled (395 intervention; 347 control); 649 women (87.5%) participated in the first follow-up and 641 women (86.4%) in the second. A majority (270, 74.6%) of women in the intervention arm attended 5 or more PST sessions. Women enrolled in Healthy Options demonstrated a 67% (RR 0.33; 95% CI: 0.22, 0.51; p-value: <0.001; corresponding to a 25.7% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters at 6 weeks postpartum. At 9 months postpartum, women enrolled in Healthy Options demonstrated a nonsignificant 26% (RR 0.74; 95% CI: 0.42, 1.3; p-value: 0.281; corresponding to a 3.2% difference in absolute risk) lower likelihood of depressive symptoms than women in control clusters. Study limitations include not using diagnostic interviews to measure depression and not blinding data collectors to intervention status during follow-up.ConclusionsThe Healthy Options intervention did not demonstrate reduction in depressive symptoms at 9 months postpartum, the primary outcome. Significant reductions were seen in depression symptoms at 6 weeks postpartum, the secondary outcome. Stepped-care interventions may be relevant for improving outcomes in the critical early postpartum window.Trial registrationClinical Trial registration number (closed to new participants) NCT02039973.

Project description:IntroductionSecondary distribution of HIV self-tests (HIVST) by HIV-negative pregnant women to male partners increases men's testing rates. We examined whether this strategy promotes male partner testing for pregnant women living with HIV (PWLHIV).MethodsWe conducted an open-label individually randomized trial in Kampala, Uganda, in which PWLHIV ≥18 years who reported a partner of unknown HIV status were randomized 2:1 to secondary distribution of HIVST for male partner(s) or standard-of-care (SOC; invitation letter to male partner for fast-track testing). Women were followed until 12 months post-partum. Male partners were offered confirmatory HIV testing and facilitated linkage to antiretroviral treatment (ART) or oral pre-exposure prophylaxis (PrEP). Using intention-to-treat analysis, primary outcomes were male partner testing at the clinic and initiation on PrEP or ART evaluated through 12 months post-partum (ClinicalTrials.gov, NCT03484533).ResultsFrom November 2018 to March 2020, 500 PWLHIV were enrolled with a median age of 27 years (interquartile range [IQR] 23-30); 332 were randomized to HIVST and 168 to SOC with 437 PWLHIV (87.4%) completing 12 months follow-up post-partum. Of 236 male partners who tested at the clinic and enrolled (47.2%), their median age was 31 years (IQR 27-36), 45 (88.3%) men with HIV started ART and 113 (61.1%) HIV-negative men started PrEP. There was no intervention effect on male partner testing (hazard ratio [HR] 1.04; 95% confidence interval [CI]: 0.79-1.37) or time to ART or PrEP initiation (HR 0.96; 95% CI: 0.69-1.33). Two male partners and two infants acquired HIV for an incidence of 0.99 per 100 person-years (95% CI: 0.12-3.58) and 1.46 per 100 person-years (95% CI: 0.18%-5.28%), respectively. Social harms related to study participation were experienced by six women (HIVST = 5, SOC = 1).ConclusionsAlmost half of the partners of Ugandan PWLHIV tested for HIV with similar HIV testing rates and linkage to ART or PrEP among the secondary distribution of HIVST and SOC arms. Although half of men became aware of their HIV serostatus and linked to services, additional strategies to reach male partners of women in antenatal care are needed to increase HIV testing and linkage to services among men.

Project description:INTRODUCTION:The success of combination antiretroviral therapy has decreased the risk of perinatal HIV transmission and normalised pregnancy in women living with HIV (WLWH). Despite these advances, WLWH still face complex medical and psychosocial issues during pregnancy and postpartum, and there is a gap of knowledge on the experiences of becoming and being a mother living with HIV in today's context. The overall aim of this study is to investigate psychosocial outcomes and experiences of WLWH in Scandinavia during pregnancy and early motherhood. METHODS AND ANALYSIS:This is a multicentre longitudinal convergent mixed methods study consisting of a quantitative survey study, a qualitative interview study and a mixed methods analysis. The survey study aims to examine psychosocial outcomes of WLWH across the pregnancy - postpartum trajectory. Participants are pregnant WLWH living in Scandinavia. Two control groups of HIV-negative pregnant women and non-pregnant WLWH are also included. Data is collected in the third trimester, 3 and 6 months postpartum using standardised questionnaires. Statistical analysis will assess changes over time and identify predictors of adverse outcomes. The interview study seeks to understand experiences of pregnancy and becoming a mother while living with HIV. Pregnant WLWH who are enrolled in the survey study will be asked to participate in individual interviews in the third trimester and 6 months postpartum. Data will be analysed using narrative analysis. The survey and interview results will be merged in a mixed methods analysis to assess confirmation, expansion or discordance between the data sets. ETHICS AND DISSEMINATION:Approval from the Danish Data Protection Agency (VD-2018-253), and the Finnish and Swedish Ethics Committees have been obtained (HUS/1330/2019 and Dnr: 2019-04451, respectively). Study results will be disseminated to patient organisations, through publications in peer-reviewed journals and at scientific conferences.

Project description:BackgroundOral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women.MethodsThe Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16-24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16-24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants' perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention's fidelity and cost.DiscussionEvidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings.Trial registrationClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

Project description:BackgroundPreterm birth is a leading cause of death in children under the age of five. The risk of preterm birth is increased by maternal HIV infection as well as by certain antiretroviral regimens, leading to a disproportionate burden on low- and medium-income settings where HIV is most prevalent. Despite decades of research, the mechanisms underlying spontaneous preterm birth, particularly in resource limited areas with high HIV infection rates, are still poorly understood and accurate prediction and therapeutic intervention remain elusive.ObjectivesMetabolomics was utilized to identify profiles of preterm birth among pregnant women living with HIV on two different antiretroviral therapy (ART) regimens.MethodsThis pilot study comprised 100 mother-infant dyads prior to antiretroviral initiation, on zidovudine monotherapy or on protease inhibitor-based antiretroviral therapy. Pregnancies that resulted in preterm births were matched 1:1 with controls by gestational age at time of sample collection. Maternal plasma and blood spots at 23-35 weeks gestation and infant dried blood spots at birth, were assayed using an untargeted metabolomics method. Linear regression and random forests classification models were used to identify shared and treatment-specific markers of preterm birth.ResultsClassification models for preterm birth achieved accuracies of 95.5%, 95.7%, and 80.7% in the untreated, zidovudine monotherapy, and protease inhibitor-based treatment groups, respectively. Urate, methionine sulfone, cortisone, and 17α-hydroxypregnanolone glucuronide were identified as shared markers of preterm birth. Other compounds including hippurate and N-acetyl-1-methylhistidine were found to be significantly altered in a treatment-specific context.ConclusionThis study identified previously known as well as novel metabolomic features of preterm birth in pregnant women living with HIV. Validation of these models in a larger, independent cohort is necessary to ascertain whether they can be utilized to predict preterm birth during a stage of gestation that allows for therapeutic intervention or more effective resource allocation.

Dataset Information

Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

Publications

Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

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