Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda.
ABSTRACT: To assess the effect of a savings-led economic empowerment intervention on viral suppression among adolescents living with HIV. Using data from Suubi?+?Adherence, a longitudinal, cluster randomized trial in southern Uganda (2012-2017), we examine the effect of the intervention on HIV RNA viral load, dichotomized between undetectable (
Project description:Improving economic resources of impoverished youth may alter intentions to engage in sexual risk behaviors by motivating positive future planning to avoid HIV risk and by altering economic contexts contributing to HIV risk. Yet, few studies have examined the effect of economic-strengthening on economic and sexual behaviors of orphaned youth, despite high poverty and high HIV infection in this population. Hierarchal longitudinal regressions were used to examine the effect of a savings-led economic empowerment intervention, the Suubi-Maka Project, on changes in orphaned adolescents' cash savings and attitudes toward savings and HIV-preventive practices over time. We randomized 346 Ugandan adolescents, aged 10-17 years, to either the control group receiving usual orphan care plus mentoring (n?=?167) or the intervention group receiving usual orphan care plus mentoring, financial education, and matched savings accounts (n?=?179). Assessments were conducted at baseline, 12, and 24 months. Results indicated that intervention adolescents significantly increased their cash savings over time (b?=?$US12.32, ±1.12, p?<?.001) compared to adolescents in the control group. At 24 months post-baseline, 92% of intervention adolescents had accumulated savings compared to 43% in the control group (p?<?.001). The largest changes in savings goals were the proportion of intervention adolescents valuing saving for money to buy a home (?T1-T0?=?+14.9, p?<?.001), pursue vocational training (?T1-T0?=?+8.8, p?<?.01), and start a business (T1-T0?=?+6.7, p?<?.01). Intervention adolescents also had a significant relative increase over time in HIV-preventive attitudinal scores (b?=?+0.19, ±0.09, p?<?.05), most commonly toward perceived risk of HIV (95.8%, n?=?159), sexual abstinence or postponement (91.6%, n?=?152), and consistent condom use (93.4%, n?=?144). In addition, intervention adolescents had 2.017 significantly greater odds of a maximum HIV-prevention score (OR?=?2.017, 95%CI: 1.43-2.84). To minimize HIV risk throughout the adolescent and young adult periods, long-term strategies are needed to integrate youth economic development, including savings and income generation, with age-appropriate combination prevention interventions.
Project description:BACKGROUND:Adequate antiretroviral exposure is crucial to virological suppression. We assessed the relationship between atazanavir hair levels with self-reported adherence, virological outcomes, and the effect of a home-based adherence intervention in HIV-infected adolescents failing second-line antiretroviral treatment in Zimbabwe. METHODS:HIV-infected adolescents on atazanavir/ritonavir-based second-line treatment for ?6 months with viral load (VL) >1000 copies/mL were randomized to either standard care (control) or standard care plus modified directly administered antiretroviral therapy (intervention). Questionnaires were administered; VL and hair samples were collected at baseline and after 90 days in each group. Viral suppression was defined as <1000 copies/mL after follow-up. RESULTS:Fifty adolescents (10-18 years) were enrolled; 23 (46%) were randomized to intervention and 27 (54%) to control. Atazanavir hair concentration <2.35 ng/mg (lower interquartile range for those with virological suppression) defined a cutoff below which most participants experienced virological failure. Male sex (P = 0.03), virological suppression at follow-up (P = 0.013), greater reduction in VL (P = 0.006), and change in average self-reported adherence over the previous month (P = 0.031) were associated with adequate (>2.35 ng/mg) hair concentrations. Participants with virological failure were more likely to have suboptimal atazanavir hair concentrations (RR = 7.2, 95% CI: 1 to 51, P = 0.049). There were no differences in atazanavir hair concentration between the arms after follow-up. CONCLUSIONS:A threshold of atazanavir concentrations in hair (2.35 ng/mg), above which virological suppression was likely, was defined for adolescents failing second-line atazanavir/ritonavir-based ART in Zimbabwe. Male sex and better self-reported adherence were associated with adequate atazanavir hair concentrations. Antiretroviral hair concentrations may serve as a useful clinical tool among adolescents.
Project description:Background:Adolescents living with human immunodeficiency virus (HIV) die owing to acquired immune deficiency syndrome (AIDS)-related causes more than adults. Although viral suppression protects people living with HIV from AIDS-related illnesses, little is known about viral outcomes of adolescents in sub-Saharan Africa where the biggest burden of deaths is experienced. This study aimed to identify the factors associated with viral load suppression among HIV-positive adolescents (10-19?years) receiving antiretroviral therapy (ART) in Uganda. Methods:We conducted a cross-sectional study among school-going, HIV-positive adolescents on ART from August to September 2016. We recruited 238 adolescents who underwent ART at a public health facility and had at least one viral load result recorded in their medical records since 2015. We collected the data of patients' demographics and treatment- and clinic-related factors using existing medical records and questionnaire-guided face-to-face interviews. For outcome variables, we defined viral suppression as <?1000 copies/mL. We used multivariate logistic regression to determine factors associated with viral suppression. Results:We analyzed the data of 200 adolescents meeting the inclusion criteria. Viral suppression was high among adolescents with good adherence >?95% (adjusted odds ratio [AOR] 2.73, 95% confidence interval [95% CI, 1.09 to 6.82). However, 71% of all adolescents who did not achieve viral suppression were also sufficiently adherent (adherence >?95%). Regardless of adherence status, other risk factors for viral suppression at the multivariate level included having a history of treatment failure (AOR 0.26, 95% CI, 0.09 to 0.77), religion (being Anglican [AOR 0.19, 95% CI, 0.06 to 0.62] or Muslim [AOR 0.17, 95% CI, 0.05 to 0.55]), and having been prayed for (AOR 0.38, 95% CI, 0.15 to 0.96). Conclusion:More than 70% of adolescents who experienced virologic failure were sufficiently adherent (adherence >?95). Adolescents who had unsuppressed viral loads in their initial viral load were more likely to experience virologic failure upon a repeat viral load regardless of their adherence level or change of regimen. The study also shows that strong religious beliefs exist among adolescents. Healthcare provider training in psychological counseling, regular and strict monitoring of adolescent outcomes should be prioritized to facilitate early identification and management of drug resistance through timely switching of treatment regimens to more robust combinations.
Project description:BACKGROUND:Adolescent HIV patients face enormous difficulty in accessing HIV care services. Given their vulnerability to risk-taking behaviour, this group also have worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control particularly in sub-Saharan Africa (SSA) as more than eight out of ten of the world's HIV-infected adolescents live in this region of the world. Limited evidence exists on the effectiveness of service delivery interventions to support adolescents' retention on antiretroviral therapy (ART) and adherence to ART. This trial is designed to evaluate the impact of conditional economic incentive and motivational interviewing on adolescents' retention in HIV care and adherence to ART in Anambra State, Southeast Nigeria. METHODS/DESIGN:The study will be a cluster randomised controlled trial that will be conducted in selected HIV treatment hospitals in Anambra State, Nigeria. Based on sample size calculation, 12 HIV treatment hospitals from Anambra will be selected for the study. Six HIV treatment hospitals each will be randomised to either the intervention or the control arm. A structured adherence support scheme termed the 'Incentive Scheme' will be applied to the intervention arm while the control arm will receive routine HIV care (usual care). Additionally, patients in the intervention arm will receive motivational interviewing at baseline and following initiation of antiretroviral therapy (ART), they will receive a gift voucher of US$5.6 when HIV viral load (VL) is <?20 copies/mL at 12?weeks, a gift voucher of US$2.8 if the VL remains suppressed for the next 3?months, and the next 6?months, and finally a gift voucher of US$5.6 if the VL remains <?20 copies/mL at 1?year. All gift vouchers will be conditional not only on VL results but attending the motivational interviews. The primary outcome for the trial will be the difference between groups in the proportion with HIV VL suppression (??20 copies/mL) by 12?months and then 24?months after withdrawal of incentive. DISCUSSION:The findings of this proposed trial will provide evidence on the feasibility of applying conditional economic incentives combined with motivational interviewing to improve retention and adherence to antiretroviral therapy of adolescents living with HIV in Nigeria and possibly in other sub-Saharan African countries. TRIAL REGISTRATION:Registered in the Pan African Clinical Trials Registry, ID: PACTR201806003040425 . Registered on 2 February 2018.
Project description:BACKGROUND:Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV. OBJECTIVE:This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms. METHODS:Women (age ?18 years) who were followed up at the women's HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants' preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants' medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits-approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable-T1 and T2 values will be compared with values at T0 by the study group. RESULTS:As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system. CONCLUSIONS:The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV. TRIAL REGISTRATION:ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17656.
Project description:In adults living with HIV, pharmacy refill data are good predictors of virologic failure (VF). The utility of pharmacy refill data for predicting VF in adolescents has not been reported. We evaluated data from 291 adolescents on antiretroviral therapy. The main outcome measure was VF, defined as two consecutive HIV viral load measurements???400 copies/mL during 24-months of follow-up. Pharmacy refill non-adherence was defined as two consecutive refill adherence measurements?<?95% during the same period. Fifty-three (18%) adolescents experienced VF. One hundred twenty-eight (44%) adolescents had refill non-adherence. Refill non-adherence had poor discriminative ability for indicating VF (receiver operating characteristic AUC?=?0.60). Sensitivity and specificity for predicting VF was poor (60% (95% CI 46-74%) and 60% (95% CI 53-66%), respectively). The lack of a viable surrogate for VF in adolescents highlights the urgent need for more access to virologic testing and novel methods of monitoring adolescent treatment adherence.
Project description:BACKGROUND:HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults. METHODS:This is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report. DISCUSSION:Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings. TRIAL REGISTRATION:ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.
Project description:Background:Globally, 1.8 million children<15 years are living with HIV. Sub-Saharan Africa (SSA), as a region, is heavily burdened by HIV, with 90% of new infections among children happening there. Within SSA, Uganda has an HIV prevalence of 7.2% among 15-49-year-olds, with high prevalence in Masaka region (12%). Uganda also reports unprecedented numbers of perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA). However adherence to antiretroviral therapy (ART) among children and youth is poor, and has been attributed to economic insecurity, including lack of finances for transportation to clinic appointments, inadequate meals to support medication consumption, and resource prioritization towards school expenses. Yet, few programs aimed at addressing ART adherence have applied combination interventions to address economic stability and ART Adherence within the traditional framework of health education and HIV care. This paper describes a study protocol for a 5-year, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded, cluster randomized-controlled trial to evaluate a combination intervention, titled Suubi + Adherence, aimed at improving ART adherence among HIV perinatally infected adolescents (ages 10-16 at study enrollment) in Uganda. Methods:Suubi + Adherence was evaluated via a two-arm cluster randomized-controlled trial design in 39 health clinics, with a total enrollment of 702 HIV + adolescents (ages 10-16 at enrollment). The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family functioning, sexual risk-taking behavior, and financial savings behavior. For potential scale-up, cost effectiveness analysis was employed to compare the relative costs and outcomes associated with each study arm: family economic strengthening comprising matched savings accounts, financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC) comprising enhanced adherence sessions to ensure more standardized and sufficient adherence counseling. Discussion:This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA. To our knowledge, the proposed study is the first to integrate and test family economic empowerment and stability-focused interventions for HIV + adolescents in Uganda (and much of SSA)-so families would have the necessary finances to manage HIV/AIDS as a chronic illness. The study would provide crucial evidence about the effects of an economic empowerment program on short and long-term impact, which is essential if such interventions are to be taken to scale. Trial registration:This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.
Project description:BACKGROUND:Adolescents living with HIV in sub-Saharan Africa are a vulnerable group at the intersection of poverty and health disparities. The family is a vital microsystem that provides financial and emotional support to achieve optimal antiretroviral therapy (ART) adherence. In this study, we explore the association between family factors and ART adherence self-efficacy, a significant psychological concept playing a critical role in ART adherence. METHODS:Data from an NIH-funded study called Suubi?+?Adherence, an economic empowerment intervention for HIV positive adolescents (average age?=?12.4?years) in southern Uganda was analyzed. We conducted multilevel regression analyses to explore the protective family factors, measured by family cohesion, child-caregiver communication and perceived child-caregiver support, associated with ART adherence self-efficacy. RESULTS:The average age was 12.4?years and 56.4% of participants were female. The average household size was 5.7 people, with 2.3 children>?18?years. Controlling for sociodemographic and household characteristics, family cohesion (??=?0.397, p?=?0.000) and child-caregiver communication (??=?0.118, p?=?0.026) were significantly associated with adherence self-efficacy to ART. CONCLUSION:Findings point to the need to strengthen family cohesion and communication within families if we are to enhance adherence self-efficacy among adolescents living with HIV. TRIAL REGISTRATION:This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.
Project description:OBJECTIVE:Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. DESIGN:Longitudinal randomized controlled trial. SETTINGS:An academic HIV clinic and a community-based organization in Seattle. SUBJECTS:In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention). INTERVENTION:Randomization to computerized counseling or assessment only, 4 sessions over 9 months. MAIN OUTCOME MEASURES:HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations. RESULTS:Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038. CONCLUSIONS:Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.