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Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART. METHODS/DESIGN:This study is a cluster randomized, 2?×?2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care. DISCUSSION:This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02491177 . Registered on 11 March 2015.

SUBMITTER: Odeny TA

PROVIDER: S-EPMC5789594 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

Odeny Thomas A TA Onono Maricianah M Owuor Kevin K Helova Anna A Wanga Iris I Bukusi Elizabeth A EA Turan Janet M JM Abuogi Lisa L LL

Trials 20180129 1

<h4>Background</h4>Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mo ...[more]

PMID: 29378622

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Project description:IntroductionRetention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced-based behavioural interventions on postpartum adherence and retention in WLWH in Kenya.MethodsThe Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster-randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty-four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text-messaging, (3) community-based mentor mothers (cMM) or (4) text-messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per-protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions.ResultsWe enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost-to-follow-up (LTFU) and 95 (7.1%) were discontinued from the study. In intention-to-treat analyses, the relative risk of being retained at 12-months postpartum was not significantly higher in the intervention arms versus the control arm. In time-to-event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per-protocol analysis, the relative risk of 12-month postpartum retention was 24-29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16-1.32, p<0.001), cMM only RR 1.29 (95% CI 1.21-1.37, p<0.001) and cMM plus text RR 1.29 (1.21-1.37, p<0.001). Women LTFU were younger (p<0.001), less likely to be married (p<0.001) and more likely to be newly diagnosed with HIV during pregnancy (p<0.001). Self-reported ART adherence did not vary by study arm.ConclusionsBehavioural interventions using peer support and text messages did not appear to improve 12-month postpartum retention and adherence in intention-to-treat analyses. Higher levels of exposure to the interventions may be necessary to achieve the desired effects.

Project description:IntroductionWe aimed to evaluate daily oral pre-exposure prophylaxis (PrEP) uptake, retention, and adherence and predictors of study non-attendance and low PrEP adherence in a Brazilian trans-specific 48-week study (PrEParadas).MethodsWe enrolled transgender women (TGW) engaging in high-risk sexual behaviours between August 2017 and December 2018. PrEP adherence was based on tenofovir diphosphate concentrations in dried blood spots (DBS). We used random effects logistic regression models and ordinal models to estimate the odds of having a missed visit and of low PrEP adherence, respectively. Multivariable models were adjusted for variables with p-value<0.10 in the univariate analysis.ResultsFrom the 271 eligible, 130 participants were enrolled in the study (PrEP uptake: 48%), out of which 111 (85.4%) were retained at 48 weeks. Multivariable model for study non-attendance included study visit, age, main sexual partner and stimulant use. The odds of missing a visit increased after the week 24. Participants aged 18-24 (adjusted odds ratio [aOR] = 8.76, 95% CI: 2.09-36.7) and 25-34 years (aOR = 6.79, 95% CI: 1.72-26.8) compared to TGW aged 35+ years had significantly higher odds of having a missed visit. The odds of a missed visit were higher among participants reporting stimulant use (aOR = 4.99, 95% CI: 1.37-18.1) compared to no stimulant use. DBS levels at week 48 showed that 42 (38.5%), 14 (12.8%) and 53 (48.6%) of 109 participants had low, moderate and high PrEP adherence. Multivariable model for low PrEP adherence included study visit, age, schooling, race/colour, housing, binge drinking, stimulant use, feminizing hormone therapy (FHT) use and received text message. Low PrEP adherence was significantly higher among participants with less years of schooling (aOR = 6.71, 95% CI: 1.30-34.5) and had a borderline association with Black colour/race (aOR = 6.72, 95% CI: 0.94-47.8). Participants using the FHT available at the site had decreased odds of low PrEP adherence (aOR = 0.38, 95% CI: 0.16-0.88). No participant seroconverted over the course of the study.ConclusionsAlthough high PrEP retention can be achieved in a gender-affirming setting, PrEP adherence may be an important challenge faced among TGW due to social disparities. The scale-up of prevention tools like PrEP will have to address systemic social determinants as these stand as important barriers for TGW's access to health services.

Project description:BackgroundRetention, defined as continuous engagement in care, is an important indicator for quality of healthcare services. To achieve UNAIDS 90-90-90 targets, emphasis on retention as a predictor of viral suppression in patients initiated on ART is vital. Using routinely collected clinical data, the authors sought to determine the effect of age on retention post ART initiation.MethodsDe-identified electronic data for 32965 HIV-infected persons aged ≥15 years at enrolment into the Academic Model Providing Access to Healthcare program between January 2008 and December 2014 were analyzed. Follow-up time was defined from the date of ART initiation until either loss to follow-up or death or close of the database (September 2016) was observed. Proportions were compared using Pearson's Chi-square test and medians using Mann-Whitney U test. Logistic regression model was used to assess differences in ART initiation between groups, adjusting for baseline characteristics. Cox proportional hazards model adjusting for baseline characteristics and antiretroviral therapy (ART) status was used to compute hazard ratios. Kaplan-Meier survival function was used to compare retention on ART at 12, 24, and 36 months post ART initiation.ResultsOf the total sample, 3924 (12.0%) were aged ≥50 years at enrolment. The median (IQR) age of young adults and older adults were 32.5 (26.6, 36.9) and 54.9 (51.7, 59.9) respectively. ART initiation rates were 70.5% among older adults and 68.2% among younger adults. Retention rates in care at 12, 24 and 36 months post ART initiation were 73.9% (95% CL: 72.2, 75.5), 62.9% (95% CL: 61.0, 64.7) and 55.4% (95% CL: 53.5, 57.3) among older adults compared to 69.8% (95% CL: 69.1, 70.4), 58.1% (95% CL: 57.4, 58.8) and 49.3% (95% CL: 48.6, 50.0) among younger adults (p <0.001). A higher proportion of older adults were retained in HIV care post ART initiation compared to younger adults, Adjusted Hazard Ratio (AHR): 0.83 (95% CI: 0.78, 0.87) though they were more likely to die, AHR: 1.35 (95% CI: 1.19, 1.52).ConclusionA higher proportion of older adults are initiated on ART and have better retention in care at 12, 24 and 36 months post ART initiation than younger adults. However, older adults have a higher all-cause mortality rate, perhaps partially driven by late presentation to care. Enhanced outreach and care to this group is imperative to improve their outcomes.

Project description:BACKGROUND: Researchers have widely documented the pervasiveness of HIV stigma and discrimination, and its impact on people living with HIV. Only a few studies, however, have analysed the perceptions of women living with HIV accessing sexual and reproductive health (SRH) services. This study explores the experiences of stigma of HIV-positive clients attending family planning and post-natal services and implications for service use and antiretroviral therapy (ART) adherence. Our aim was to gain a better understanding of the impact of various dimensions of stigma on service use and ART adherence among HIV clients in order to inform the response of integrated SRH services. METHODS: In-depth interviews were conducted with 48 women living with HIV attending SRH services in two districts in Kenya. Data were coded using Nvivo 8 and analysed using a thematic analysis approach. RESULTS: Findings show that many women living with HIV report high levels of anticipated stigma, resulting in a desire to hide their status from family and friends for fear of being discriminated against. Many women feared desertion following disclosure of their positive status to partners. Consequently some women preferred to hide their status and adhere to HIV treatment in secret. However, the majority of study participants attending postnatal care (PNC) services also revealed that anticipated stigma does not adversely affect their HIV drug uptake and ART adherence, as their drive to live outweighs their fear of stigma. Our findings also seem to suggest a preference for specialist HIV services by some family planning (FP) clients because of better confidentiality and reduced opportunities for unwanted disclosure that could lead to stigma. CONCLUSIONS: The findings highlight that anticipated stigma leading to low disclosure is widespread and sometimes reinforced by health providers' actions and facility layout (contributing to enacted stigma). However, the motivation to stay healthy and look after the children appears in many cases to override fears of stigma related to ART adherence in our client-based sample.

Project description:BackgroundAccording to the World Health Organization, in 2018, 37.9 million people were living with HIV globally. More than two-thirds were residing in sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49 years) was 3.9%. This population included 1.3 million pregnant women, of whom 82% had received antiretroviral therapy (ART) for the prevention of HIV mother-to-child transmission. In these countries, one challenge is an insufficient level of treatment adherence, particularly in HIV-positive pregnant women. Among the causes, the lack of involvement from a male partner is a significant contributor to the problem. This issue has strongly emerged in Malawi, one of the countries with the highest HIV prevalence in the world: 9.2% of its adult population were living with HIV in 2018.ObjectiveThis study aims to assess 3 interventions that are aimed at improving ART adherence and retention among HIV-positive women through engagement with their male partners in 4 Malawian health care centers.MethodsThe prospective, controlled before-and-after study is conducted in 3 phases (total duration: 24 months): preintervention, intervention, and postintervention analyses. The number of selected clusters (clinical centers) is limited to 4: one for each intervention, plus a cluster where no intervention is performed (control arm). The interventions are as follows: opening the facility on one Saturday per month only for men, defined as a special day; testing peer-to-peer counseling among men, male champions; and providing a noneconomic incentive to all women who are accompanied by their partners to the facility, nudge. The primary outcome of the study is to evaluate the differences in retention in care and adherence to therapeutic protocols among women; the intermediate outcome is the assessment of differences in male involvement. The level of male involvement in the health of their partners (intermediate outcome) will be evaluated through a dedicated questionnaire administered at baseline and in the postintervention phase. Data will be collected at the clinical centers and stored in 2 electronic databases managed using 2 different types of software.ResultsThe analysis of data collected in the 4 centers during the preintervention phase is ongoing, as enrollment ended on March 31, 2020. The total number of patients enrolled was 452 (Namandanje: 133; Kapeni: 78; Kapire: 75; and Balaka: 166). Meanwhile, several meetings have been conducted to organize the intervention phase.ConclusionsThe study will identify the best intervention that enhances the involvement of male partners in women's health, using an approach that considers a broad spectrum of behaviors. An important aspect is the use of educational tools focused on messages, thereby initiating a reflective discussion of stereotypes and false beliefs related to the idea of masculinity present in the Malawian culture.International registered report identifier (irrid)DERR1-10.2196/19384.

Project description:IntroductionAdherence to antiretroviral therapy (ART) and retention in treatment programs are required for successful virologic suppression and treatment outcomes. As the number of adolescents living with HIV continues to increase globally, more information about adherence and retention patterns during and through transition from child- to adult-centered care is needed to ensure provision of a high level of care and inform development of targeted interventions to improve patient outcomes in this vulnerable population. In this analysis, we sought to describe long-term trends in adherence, retention, and virologic suppression in adolescents receiving ART at a pediatric HIV clinic in Nigeria through transition to the adult clinic.SettingThe Jos University Teaching Hospital, United States President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV clinic in Jos, Plateau State, Nigeria.MethodsWe conducted a retrospective observational longitudinal evaluation of data that had been collected during the course of care in a large pediatric ART program in Nigeria. We used descriptive statistics to define our patient population and quantify retention from ART initiation through adolescence and transition to adult-centered care. Logistic regression was used to evaluate predictors of loss to follow-up. We used medication possession ratio (MPR) to quantify adherence for each year a patient was on ART. To evaluate adherence and virologic suppression, we measured the proportion of patients with ≥95% MPR and the proportion with virologic suppression (viral load ≤400 copies/mL) within each age cohort, and used bivariate analyses to examine any association between MPR and VL suppression for all person-years observed.ResultsA total of 476 patients received at least one dose of ART as an adolescent (ages 10-19 years). The proportions of patients lost to follow-up were: 11.9% (71/597) prior to adolescence, 19.1% (31/162) during adolescence, and 13.7% (10/73) during transition to adult-centered care. While over 80% of patients had ≥95% medication adherence in all age groups, their viral load suppression rates through adolescence and post-transition were only 55.6%-64.0%. For patients that successfully transitioned to adult-centered care, we observed 87.7% (50/57) retention at month 12 post-transition, but only 34.6% (9/26) viral load suppression.ConclusionsOur evaluation found considerable proportions of adolescents lost to follow-up throughout the ART program cascade. We also found discrepancies between the proportions of patients with ≥95% MPR and the proportions with VL suppression, suggesting that true medication adherence in this population may be poor. Significant attention and targeted interventions to improve retention and adherence focused on adolescents are needed in order for global programs to achieve 90-90-90 goals.

Dataset Information

Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

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Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

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