Suchergebnisse

AbstractIntroductionTo maximize impact and minimize costs, antiretroviral pre‐exposure prophylaxis (PrEP) interventions should be offered to those at highest risk for HIV infection. The risk score derived from the VOICE trial is one tool currently being utilized to determine eligibility in adolescent PrEP trials in sub‐Saharan Africa. This study is aimed at evaluating the utility of the risk score in predicting HIV incidence among a cohort of adolescent girls in rural South Africa.MethodsWe utilized data from HIV Prevention Trials Network (HPTN) 068, a phase III randomized controlled trial conducted in rural Mpumalanga province, South Africa. School‐attending young women aged 13 to 20 years were enrolled into the trial from 2011 to 2012 and followed for up to three years. A risk score based on individual‐level risk factors measured at enrolment was calculated for HPTN 068 participants who completed a one‐year follow‐up visit and were HIV seronegative at enrolment. Possible scores ranged from 0 to 10. A proportional hazards model was then used to determine if risk score at enrolment was predictive of incident HIV infection at follow‐up and an area under the curve analysis was used to examine the predictive ability of the score.Results and DiscussionThe risk score had limited variability in the HPTN 068 sample. Scores ≥5 identified 85% of incident infections from 94% of the sample, compared to the VOICE sample in which scores ≥5 identified 91% of incident infections from only 64% of participants. The risk score did not predict HIV incidence after one year of follow‐up (hazard ratio = 1.029; 95% confidence interval (CI): 0.704, 1.503, p = .884) and showed poor predictive ability (area under the curve = 0.55; 95% CI: 0.44, 0.65). Certain individual risk factors that comprise the risk score may be context specific or not relevant for adolescent populations. Additional factors should be considered when assessing risk for the purposes of determining PrEP eligibility.ConclusionsThe VOICE risk score demonstrated low utility to predict HIV incidence in the HPTN 068 sample. Findings highlight the need for an age and developmentally appropriate tool for assessing risk for HIV infection among adolescents. Use of the VOICE risk score for determining PrEP eligibility in younger populations should be carefully considered.

AbstractIntroductionEvidence has shown that the experience of violence by a partner has important influences on women's risk of HIV acquisition. Using a randomized experiment in northeast South Africa, we found that a conditional cash transfer (CCT) targeted to poor girls in high school reduced the risk of physical intimate partner violence (IPV) in the past 12 months by 34%. The purpose of this analysis is to understand the pathways through which the CCT affects IPV.MethodsHPTN 068 was a phase 3, randomized controlled trial in rural Mpumalanga province, South Africa. Eligible young women (aged 13–20) and their parents or guardians were randomly assigned (1:1) to either receive a monthly cash transfer conditional on monthly high school attendance or no cash transfer. Between 2011 and 2015, participants (N = 2,448) were interviewed at baseline, then at annual follow‐up visits at 12, 24 and 36 months. The total effect of the CCT on IPV was estimated using a GEE log‐binomial regression model. We then estimated controlled direct effects to examine mediation of direct effects through intermediate pathways. Mediators include sexual partnership measures, the sexual relationship power scale, and household consumption measures.ResultsWe found evidence that the CCT works in part through delaying sexual debut or reducing the number of sexual partners. The intervention interacts with these mediators leading to larger reductions in IPV risk compared to the total effect of the CCT on any physical IPV [RR 0.66, CI(95%):0.59–0.74]. The largest reductions are seen when we estimate the controlled direct effect under no sexual debut [RR 0.57, CI(95%):0.48–0.65] or under no sexual partner in the last 12 months [RR 0.53, CI(95%):0.46–0.60].ConclusionsResults indicate that a CCT for high school girls has protective effects on their experience of IPV and that the effect is due in part to girls choosing not to engage in sexual partnerships, thereby reducing the opportunity for IPV. As a lower exposure to IPV and safer sexual behaviours also protect against HIV acquisition, this study adds to the growing body of evidence on how cash transfers may reduce young women's HIV risk.

AbstractIntroductionHIV testing is a required part of delivery of pre‐exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under‐staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility‐based HIV self‐testing (HIVST) among young women using PrEP in an implementation programme.MethodsBetween February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow‐up visit, women were given the option to choose between provider‐initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST.ResultsA total of 172 women were offered HIVST at 202 PrEP follow‐up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow‐up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p < 0.001). Women who accepted HIVST had shorter visits than those choosing standard provider‐initiated HIV testing (median [IQR]: 33 [32, 38] vs. 54 [41.5, 81] minutes, p = 0.003).ConclusionsIn this pilot evaluation in Kenya, about one‐third of women using PrEP opted for HIVST over provider‐initiated testing, and those choosing HIVST spent less time in the clinic and were generally satisfied with their experience. HIVST in PrEP delivery is feasible and has the potential to simplify PrEP delivery and give clients testing autonomy. Additional studies are needed to explore optimal HIV retesting strategies in PrEP delivery, including the use of HIVST in PrEP at a larger scale and in different settings.

This study aims to evaluate condom use, STI screening, and knowledge of STI symptoms among female sex workers (FSW) in Peru associated with sex work venue and a community randomized trial of STI control. One component of the Peru PREVEN intervention conducted mobile-team outreach to FSW to reduce STIs and increase condom use and access to government clinics for STI screening and evaluation. Prevalence ratios were calculated using multivariate Poisson regression models with robust standard errors, clustering by city. As-treated analyses were conducted to assess outcomes associated with reported exposure to the intervention. Care-seeking was more frequent in intervention communities, but differences were not statistically significant. FSW reporting exposure to the intervention had significantly higher likelihood of condom use, STI screening at public health clinics, and symptom recognition compared to those not exposed. Compared with street or bar-based FSW, brothel-based FSW reported significantly higher rates of condom use with last client, recent screening exams for STIs and HIV testing. Brothel-based FSW also more often reported knowledge of STIs and recognition of STI symptoms in women and in men. Interventions to promote STI-detection and prevention among FSW in Peru should consider structural or regulatory factors related to sex work venue.

Abstract Background Since the rapid scale-up of antiretroviral therapy (ART) programs in sub-Saharan Africa, electronic patient tracking systems (EPTS) have been deployed to respond to the growing demand for program monitoring, evaluation and reporting to governments and donors. These routinely collected data are often used in epidemiologic and operations research studies intended to improve programs. To ensure accurate reporting and good quality for research, the reliability and completeness of data systems need to be assessed and reported. We assessed the completeness and reliability of EPTS used in 16 HIV care and treatment clinics in Manica and Sofala provinces of Mozambique. Methods We conducted a cross-sectional study to assess the completeness and reliability of key variables in the electronic data system for patients enrolling in 16 public sector HIV treatment clinics between 1 July 2004 and 30 June 2008. Data from the electronic database was compared with data abstracted from a stratified random sample of 520 patient charts. Percent agreement, kappa scores and concordance correlation coefficients were calculated for specified variables. Percentile bootstrap confidence intervals were calculated to account for the stratified nature of our sampling. Results A total of 16,149 patients with a median age of 33 years and a median CD4 count of 151 enrolled in these 16 clinics between 1 July 2004 and 30 June 2008. The level of completeness was high for most variables with height (18.6%) and weight (11.5%) having the highest amount of missing data. The level of agreement for available data was also high with reliability statistics of 0.95 (95% CI: 0.92-0.98) for gender, 0.91 (95% CI: 0.80-1.00) for pre-ART CD4 value and 0.97 (95% CI: 0.95-0.99) for patient retention. Conclusions Electronic patient tracking systems have been deployed to respond to the growing monitoring, evaluation and reporting requirements. In our cross-sectional study of clinics in Manica and Sofala provinces of Mozambique, we found high levels of completeness and reliability for key variables indicating that these electronic databases provided adequate data not only for monitoring and evaluation but also for research. Routine evaluations of the completeness and reliability of these databases need to occur to ensure high quality data are being used for reporting and research.

BACKGROUND: The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal. METHODS: We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N(1) = 200) and prediabetes (N(2) = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. Outcomes will be analyzed on an intention-to-treat basis. DISCUSSION: The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019.

Background The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing a standard diabetes program in Nepal. Methods We will conduct a two-arm, parallel group, stratified cluster randomized controlled trial of the NUrse-led COntinuum of care for people with Diabetes (N1 = 200) and prediabetes (N2 = 1036) (NUCOD) program, with primary care centers (9 outreach centers and 17 government health posts) as a unit of randomization. The NUCOD program will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared with the usual treatment group at 6 and 12 months of the intervention. The primary outcome will be the change in glycated hemoglobin (HbA1c) level among diabetes individuals and progression to type 2 diabetes among prediabetes individuals, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. Outcomes will be analyzed on an intention-to-treat basis. Discussion The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and prediabetes individuals, and implementation outcomes for the organization. The continuum of care model can be used for the prevention and management of diabetes and other noncommunicable diseases within and beyond Nepal with similar context. Trial registration ClinicalTrials.gov, NCT04131257. Registered on 18 October 2019. ; This study will be conducted under the umbrella of a large implementation project and will be supported by a World Diabetes Foundation (WDF17-1483) grant, a China Medical Board (CMB16–260) grant and Dhulikhel Hospital Kathmandu University. However, the funding organizations will have no role in the design of the study, data collection, data analysis, data interpretation or writing of the report.

AbstractIntroductionTuberculosis (TB) is the leading cause of HIV‐associated mortality in Africa. As HIV testing, linkage to care and antiretroviral treatment initiation intensify to meet UNAIDS targets, it is not known what effect these efforts will have on TB detection and prevention. We aimed to characterize the TB care cascade of screening, diagnostic testing, treatment and provision of isoniazid preventive therapy (IPT) in a study of community‐based HIV screening and linkage to care and determine whether symptom screening results affected progress along the cascade.MethodsBetween June 2013 and March 2015, HIV‐infected adults enrolled in the Linkages study, a multi‐site, community‐based, randomized HIV screening and linkage‐to‐care study in South Africa and Uganda. All participants were screened for TB symptoms at entry after testing positive for HIV and referred to local clinics for care. During the 9 month follow‐up, participants were periodically surveyed about clinic linkage and initiation of HIV care as well as subsequent TB testing, treatment, or IPT. We compared outcomes between persons with and without a positive symptom screen at baseline using descriptive statistics and Poisson regression to calculate relative risks of outcomes along the care cascade.Results and discussionOf the 1,325 HIV‐infected adults enrolled, 26% reported at least one TB symptom at the time of HIV diagnosis. Loss of appetite and fever were the most commonly reported symptoms on a TB symptom screen. Despite 92% HIV linkage success, corresponding TB linkage was incomplete. Baseline TB symptoms were associated with an increased risk of a TB diagnosis (relative risk 3.23, 95% CI 1.51 to 6.91), but only 34% of symptomatic persons had sputum TB testing. Fifty‐five percent of participants diagnosed with TB started TB treatment. In South Africa, only 18% of asymptomatic participants initiated IPT after linkage to HIV care, and presence of symptoms was not associated with IPT initiation (relative risk 0.86 95% CI 0.6 to 1.23).ConclusionsHIV linkage to care interventions provide an opportunity to improve completion of the TB care cascade, but will require additional support to realize full benefits.

AbstractIntroductionMultiple antiretroviral agents have demonstrated efficacy for human immunodeficiency virus (HIV) pre‐exposure prophylaxis (PrEP). As a result, clinical trials of novel agents have transitioned from placebo‐ to active‐controlled designs; however, active‐controlled trials do not provide an estimate of efficacy versus no use of PrEP. Counterfactual placebo comparisons using other data sources could be employed to provide this information.MethodsWe compared the active‐controlled study (HPTN 084) of injectable cabotegravir (CAB‐LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) among women from seven countries in Africa to three external, contemporaneous randomized HIV prevention trials from which we constructed counterfactual placebo estimates. We used direct standardization via analysis weights to achieve the same distribution of person‐years between the external study and HPTN 084, across strata predictive of HIV risk (country and selected risk covariates). We estimated prevention efficacy against a counterfactual placebo to provide information on the use of CAB‐LA and FTC/TDF compared to no intervention. We compared the counterfactual placebo findings for FTC/TDF to previous placebo‐controlled trials, adjusted for observed adherence to daily pills.ResultsDistribution of age and baseline prevalence of gonorrhoea and chlamydia were similar among matched counterfactual placebo and observed HPTN 084 arms after standardization. Counterfactual estimates of CAB‐LA versus placebo in all three settings showed a consistent risk reduction of 93%–94%, with lower bounds of the confidence intervals above 72%. Observed adherence (quantifiable tenofovir in plasma) in HPTN 084 was 54%–56%, and estimated efficacy of daily oral FTC/TDF against a counterfactual placebo was consistent with a predicted risk reduction of 39%–40% for this level of daily pill use.ConclusionsCounterfactual placebo rates of HIV acquisition derived from external trial data in similar locations and time can be used to support estimates of placebo‐based efficacy of a novel HIV prevention agent. External trial data must be standardized to be representative of the clinical trial cohort testing the novel HIV prevention agent, accounting for confounders.

IntroductionYoung adolescent women in sub‐Saharan Africa are three to four times more likely to be HIV‐positive than boys or men. One of the relationship dynamics that is likely to be associated with young women's increased vulnerability to HIV is transactional sex. There are a range of HIV‐related risk behaviours that may drive this vulnerability. However, to date, limited epidemiological data exist on the role of transactional sex in increasing HIV acquisition, especially among young women in sub‐Saharan Africa. Our paper presents data on the prevalence of self‐reported engagement in transactional sex and explores whether transactional sex is associated with increased risk of HIV infection among a cohort of young, rural, sexually active South African women. We also explore whether this relationship is mediated through certain HIV‐related risk behaviours.MethodsWe analyzed baseline data from a phase III trial of conditional cash transfers for HIV prevention of 693 sexually active, school‐going young women aged 13–20 years in rural South Africa. We examined the association between young women's engagement in transactional sex and HIV infection. Transactional sex is defined as a non‐commercial, non‐marital sexual relationship whereby sex is exchanged for money and/or gifts. We explored whether this relationship is mediated by certain HIV‐related risk behaviours. We used logistic and multinomial regression and report unadjusted and adjusted odds ratios with 95% CI.ResultsOverall, 14% (n=97) of sexually active young women reported engaging in transactional sex. Engagement in transactional sex was associated with an increased risk of being HIV‐positive (aOR: 2.5, CI: 95% 1.19–5.25, p=0.01). The effect size of this association remained nearly unchanged when adjusted for certain other dimensions of HIV risk that might help explain the underlying pathways for this relationship.ConclusionsThis study provides quantitative support demonstrating that transactional sex is associated with HIV infection in young women. Even though the specific variables tested do not mediate the relationship, a potential explanation for this association may be that the men with whom young women are having sex belong to networks of sexually connected individuals who are at a "high risk" for HIV infection. The results highlight the importance of structural intervention approaches that can alter the context of young women's HIV risk.

AbstractIntroductionHIV prevalence is high among men who have sex with men (MSM) in Baltimore, Maryland, United States, and the levels of viral suppression among HIV‐positive MSM are relatively low. The HIV Prevention Trials Network 078 trial seeks to increase the levels of viral suppression among US MSM by increasing the rates of diagnosis and linkage to care and treatment. We estimated the increases in viral suppression needed to reach different HIV incidence reduction targets, and the impact of meeting diagnosis and treatment targets.MethodsWe used a mathematical model of HIV transmission among MSM from Baltimore, US, parameterised with behavioural data and fitted to HIV prevalence and care continuum data for Baltimore wherever possible, to project increases in viral suppression needed to reduce the HIV incidence rate among Baltimore MSM by 10, 20, 30 or 50% after 2, 5 and 10 years. We also projected HIV incidence reductions achieved if US national targets – 90% of people living with HIV (PLHIV) know their HIV serostatus, 90% of those diagnosed are retained in HIV medical care and 80% of those diagnosed are virally suppressed – or UNAIDS 90‐90‐90 targets (90% of PLHIV know their status, 90% of those diagnosed receive antiretroviral therapy (ART), 90% of those receiving ART are virally suppressed) are each met by 2020.ResultsTo reduce the HIV incidence rate by 20% and 50% after five years (compared with the base‐case at the same time point), the proportion of all HIV‐positive MSM who are virally suppressed must increase above 2015 levels by a median 13 percentage points (95% uncertainty interval 9 to 16 percentage points) from median 49% to 60%, and 27 percentage points (22 to 35) from 49% to 75% respectively. Meeting all three US or 90‐90‐90 UNAIDS targets results in a 48% (31% to 63%) and 51% (38% to 65%) HIV incidence rate reduction in 2020 respectively.ConclusionsSubstantial improvements in levels of viral suppression will be needed to achieve significant incidence reductions among MSM in Baltimore, and to meet 2020 US and UNAIDS targets. Future modelling studies should additionally consider the impact of pre‐exposure prophylaxis for MSM.