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Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

ABSTRACT: In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services.We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors.The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address.NCT02417233, registered 12 December 2014.

SUBMITTER: Lippman SA

PROVIDER: S-EPMC4744624 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

Lippman Sheri A SA Shade Starley B SB Sumitani Jeri J DeKadt Julia J Gilvydis Jennifer M JM Ratlhagana Mary Jane MJ Grignon Jessica J Tumbo John J Gilmore Hailey H Agnew Emily E Saberi Parya P Barnhart Scott S Steward Wayne T WT

Trials 20160206

<h4>Background</h4>In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messagin ...[more]

PMID: 26852237

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Project description:IntroductionFew interventions have demonstrated improved retention in care for people living with HIV (PLHIV) in sub-Saharan Africa. We tested the efficacy of two personal support interventions - one using text messaging (SMS-only) and the second pairing SMS with peer navigation (SMS+PN) - to improve HIV care retention over one year.MethodsIn a cluster randomized control trial (NCT# 02417233) in North West Province, South Africa, we randomized 17 government clinics to three conditions: SMS-only (6), SMS+PN (7) or standard of care (SOC; 4). Participants at SMS-only clinics received appointment reminders, biweekly healthy living messages and twice monthly SMS check-ins. Participants at SMS+PN clinics received SMS appointment reminders and healthy living messages and spoke at least twice monthly with peer navigators (PLHIV receiving care) to address barriers to care. Outcomes were collected through biweekly clinical record extraction and surveys at baseline, six and 12 months. Retention in HIV care over one year was defined as clinic visits every three months for participants on antiretroviral therapy (ART) and CD4 screening every six months for pre-ART participants. We used generalized estimating equations, adjusting for clustering by clinic, to test for differences across conditions.ResultsBetween October 2014 and April 2015, we enrolled 752 adult clients recently diagnosed with HIV (SOC: 167; SMS-only: 289; SMS+PN: 296). Individuals in the SMS+PN arm had approximately two more clinic visits over a year than those in other arms (p < 0.01) and were more likely to be retained in care over one year than those in SOC clinics (54% vs. 38%; OR: 1.77, CI: 1.02, 3.10). Differences between SMS+PN and SOC conditions remained significant when restricting analyses to the 628 participants on ART (61% vs. 45% retained; OR: 1.78, CI: 1.08, 2.93). The SMS-only intervention did not improve retention relative to SOC (40% vs. 38%, OR: 1.12, CI: 0.63, 1.98).ConclusionsA combination of SMS appointment reminders with personalized, peer-delivered support proved effective at enhancing retention in HIV care over one year. While some clients may only require appointment reminders, the SMS+PN approach offers increased flexibility and tailored, one-on-one support for patients struggling with more substantive challenges.

Project description:BackgroundAdequate antenatal care is important to both the health of a pregnant woman and her unborn baby. Given South Africa's high rate of cellphone penetration, mobile health interventions have been touted as a potentially powerful means to disseminate health information. This study aimed to increase antenatal health knowledge and awareness by disseminating text messages about clinic procedures at antenatal visits, and how to be healthy during pregnancy.MethodsParticipants recruited were pregnant women attending a primary health care facility in Cape Town. A controlled clinical trial was carried out where the intervention group (n = 102) received text messages staggered according to the week of pregnancy at the time of recruitment. The control group (n = 104) received no text messages. These text messages contained antenatal health information, and were delivered in English, Xhosa or Afrikaans, according to the preference of each participant. A baseline knowledge questionnaire with nine questions was administered prior to the intervention. The same questionnaire was used with added health-related behaviour questions for the intervention group at exit. A modified intention-to-treat analysis was done. To compare the control and intervention group's knowledge, Fisher's exact tests and two-sample t-tests tests were carried out for binary and continuous outcomes, respectively. A focus group of seven participants from the intervention group was then conducted to gain more insight into how the text messages were perceived.ResultsThere was substantial loss to follow-up during the study with only 57% of the participants retained at exit. No statistically significant difference was detected between the control and intervention group in any of the nine knowledge questions at exit (all p > 0.05). Responses from the focus group indicated that the text messages acted as a welcome reminder and a source of positive motivation, and were perceived as extended care from the health care provider.ConclusionsWhile the intervention failed to improve antenatal health knowledge, evidence from self-reported behaviour and the focus group suggests that text messages have the potential to motivate change in health-seeking behaviour. One should be mindful of loss to follow-up when rolling out mobile health interventions in developing country settings.Trial registrationPan African Clinical Trials Registry PACTR201406000841188. Registered 3 June 2014.

Project description:BACKGROUND:HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. METHODS/DESIGN:Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention exposure and community level change using validated measures of CM. DISCUSSION:Given the known importance of community social factors with regard to uptake of testing and HIV care, and the lack of rigorously evaluated community-level interventions effective in improving testing uptake, linkage and retention, the proposed study will yield much needed data to understand the potential of CM to improve the prevention and care cascade. Further, our work in developing a CM framework and domain measures will permit validation of a CM conceptual framework and process, which should prove valuable for community programming in Africa. TRIAL REGISTRATION:NCT02197793 Registered July 21, 2014.

Project description:BackgroundCommunity mobilisation, engaging communities in a process to collectively enact change, could improve HIV testing and care engagement. In South Africa, current rates fall below those needed for epidemic control. We assessed whether community mobilisation increased HIV testing, linkage to care, and retention in care over time in intervention relative to control communities.MethodsWe conducted a cluster-randomised controlled trial in villages in the Agincourt sub-district of the rural Mpumalanga Province in South Africa. 15 villages were randomly assigned to either a community mobilisation intervention engaging residents to address social barriers to HIV testing and treatment (intervention arm) or to a control arm using balanced randomisation. Villages were eligible if they had been fully enumerated in 2014, had not been included in previous mobilisation activities, and included over 500 permanent adult residents aged 18-49 years. Primary outcomes included quarterly rates of HIV testing, linkage to care, and retention in care documented from health facility records among residents of the intervention and control communities over the 3-year study period. Intention-to-treat analyses employed generalised estimating equations stratified by sex. This trial is registered with ClinicalTrials.gov, NCT02197793.FindingsBetween Aug 1, 2015, and July 31, 2018, residents in eight intervention communities (n=20 544 residents) and seven control communities (n=17 848) contributed data; 92 residents contributed to both arms. Among men, HIV testing increased quarterly by 12·1% (relative change [RC] 1·121, 95% CI 1·099 to 1·143, p<0·0001) in the intervention communities and 9·5% (1·095, 1·075 to 1·114, p=0·011) in the control communities; although increases in testing were greater in the intervention villages, differences did not reach significance (exponentiated interaction coefficient 1·024, 95% CI 0·997 to 1·052, p=0·078). Among women, HIV testing increased quarterly by 10·6% (RC 1·106, 95% CI 1·097 to 1·114, p<0·0001) in the intervention communities and 9·3% (1·093, 1·084 to 1·102, p=0·053) in the control communities; increases were greater in intervention communities (exponentiated interaction coefficient 1·012, 95% CI 1·001 to 1·023, p=0·043). Quarterly linkage increased significantly among women in the intervention communities (RC 1·013, 95% CI 1·002 to 1·023, p=0·018) only. Quarterly linkage fell among men in both arms, but decreased significantly among men in the control communities (0·977, 0·954 to 1·002, p=0·043). Quarterly retention fell among women in both arms; however, reductions were tempered among women in the intervention communities (exponentiated interaction coefficient 1·003, 95% CI <1·000 to 1·006, p=0·062). Retention fell significantly among men in both arms with difference in rates of decline.InterpretationCommunity mobilisation was associated with modest improvements in select trial outcomes. The sum of these incremental, quarterly improvements achieved by addressing social barriers to HIV care engagement can impact epidemic control. However, achieving optimal impacts will probably require integrated efforts addressing both social barriers through community mobilisation and provision of improved service delivery.FundingUS National Institutes of Health, National Institute of Mental Health, and United States President's Emergency Plan for AIDS Relief through Right to Care and Project SOAR.

Project description:BackgroundPoverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa.MethodsThis was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n?=?2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n?=?1,984) received usual tuberculosis care.ResultsIntention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P?=?0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose-response relationship between frequency of receipt of the voucher and treatment success (P <0.001).ConclusionsOur pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.

Project description:PurposePregnant and postpartum women living with HIV in South Africa are at high risk of dropping out of care, particularly after delivery. Population mobility may contribute to disruptions in HIV care, and postpartum women are known to be especially mobile. To improve engagement in HIV care during the peripartum period, we developed CareConekta, a smartphone application (app) that uses GPS coordinates to characterise mobility and allow for real-time intervention. We conducted a randomised controlled pilot study to assess feasibility, acceptability and initial efficacy of the app intervention to improve engagement in HIV care. This cohort profile describes participant enrolment and follow-up, describes the data collected and provides participant characteristics.ParticipantsWe enrolled 200 pregnant women living with HIV attending routine antenatal care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. Eligible women must have owned smartphones that met the app's technical requirements. Seven participants were withdrawn near enrolment, leaving 193 in the cohort.Findings to dateData were collected from detailed participant questionnaires at enrolment and follow-up (6 months after delivery), as well as GPS data from the app, and medical records. Follow-up is complete; initial analyses have explored smartphone ownership, preferences and patterns of use among women screened for eligibility and those enrolled in the study.Future plansAdditional planned analyses will characterise mobility in the population using the phone GPS data and participant self-reported data. We will assess the impact of mobility on engagement in care for the mother and infant. We also will describe the acceptability and feasibility of the study, including operational lessons learnt. By linking this cohort to the National Health Laboratory Service National HIV Cohort in South Africa, we will continue to assess engagement in care and mobility outcomes for years to come. Collaborations are welcome.Trial registration numberNCT03836625.

Dataset Information

Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

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Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

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