Effect of isoniazid preventive therapy on tuberculosis incidence and associated risk factors among HIV infected adults in Tanzania: a retrospective cohort study.

BACKGROUND: Tuberculosis (TB) continues to be the leading cause of morbidity and mortality among human immunodeficiency virus (HIV) infected individuals in Sub Saharan Africa including Tanzania. Provision of isoniazid preventive therapy (IPT) is one of the public health interventions to reduce the burden of TB among HIV infected persons. However there is limited information about the influence of IPT on TB incidence in Tanzania. This study aimed at ascertaining the effect of IPT on TB incidence and to determine risk factors for TB among HIV positive adults in Dar es Salaam region. METHODS: A retrospective cohort study was conducted using secondary data of HIV positive adults receiving care and treatment services in Dar es Salaam region from 2011 to 2014. TB incidence rate among HIV positive adults on IPT was compared to those who were not on IPT during the follow up period. Risk factors for incident TB were estimated using multivariate Cox proportional hazards regression model. RESULTS: A total of 68,378 HIV positive adults were studied. The median follow up time was 3.4 (IQR = 1.9-3.8) years for patients who ever received IPT and 1.3 (IQR = 0.3-1.3) years among those who never received IPT. A total of 3124 TB cases occurred during 114,926 total person-years of follow up. The overall TB incidence rate was 2.7/100 person-years (95%CI; 2.6-2.8). Patients on IPT had 48% lower TB incidence rate compared to patients who were not on IPT (IRR = 0.52, 95%CI; 0.46-0.59). Factors associated with higher risk for incident TB included; being male (aHR = 1.8, 95% CI; 1.6-2.0), WHO stage III (aHR = 2.7, 95% CI; 2.3-3.3) and IV (aHR = 2.4, 95% CI; 1.9-3.1),being underweight (aHR = 1.7, 95% CI; 1.5-1.9) while overweight (aHR = 0.7, 95% CI; 0.6-0.8), obese (aHR = 0.5, 95% CI; 0.4-0.7), having baseline CD4 cell count between 200 and 350 cells/µl (aHR = 0.7, 95% CI; 0.6-0.8) and CD4 count above 350 cells/µl (aHR = 0.5, 95% CI; 0.4-0.6) were associated with lower risk of developing TB. CONCLUSION: Isoniazid preventive therapy (IPT) has shown to be effective in reducing TB incidence among HIV infected adults in Dar es Salaam. More efforts are needed to increase the provision and coverage of IPT.

The Causal Effect of Tracing by Peer Health Workers on Return to Clinic Among Patients Who Were Lost to Follow-up From Antiretroviral Therapy in Eastern Africa: A "Natural Experiment" Arising From Surveillance of Lost Patients.

BACKGROUND.: The effect of tracing human immunodeficiency virus (HIV)-infected patients who are lost to follow-up (LTFU) on reengagement has not been rigorously assessed. We carried out an ex post analysis of a surveillance study in which LTFU patients were randomly selected for tracing to identify the effect of tracing on reengagement. METHODS.: We evaluated HIV-infected adults on antiretroviral therapy who were LTFU (>90 days late for last visit) at 14 clinics in Uganda, Kenya, and Tanzania. A random sample of LTFU patients was selected for tracing by peer health workers. We assessed the effect of selection for tracing using Kaplan-Meier estimates of reengagement among all patients as well as the subset of LTFU patients who were alive, contacted in person by the tracer, and out of care. RESULTS.: Of 5781 eligible patients, 991 (17%) were randomly selected for tracing. One year after selection for tracing, 13.3% (95% confidence interval [CI], 11.1%-15.3%) of those selected for tracing returned compared with 10.0% (95% CI, 9.1%-10.8%) of those not randomly selected, an adjusted risk difference of 3.0% (95% CI, .7%-5.3%). Among patients found to be alive, personally contacted, and out of care, tracing increased the absolute probability of return at 1 year by 22% (95% CI, 7.1%-36.2%). The effect of tracing on rate of return to clinic decayed with a half-life of 7.0 days after tracing (95% CI, 2.6 %-12.9%). CONCLUSIONS.: Tracing interventions increase reengagement, but developing methods for targeting LTFU patients most likely to benefit can make this practice more efficient.

Retention in Care and Patient-Reported Reasons for Undocumented Transfer or Stopping Care Among HIV-Infected Patients on Antiretroviral Therapy in Eastern Africa: Application of a Sampling-Based Approach.

BACKGROUND: Improving the implementation of the global response to human immunodeficiency virus requires understanding retention after starting antiretroviral therapy (ART), but loss to follow-up undermines assessment of the magnitude of and reasons for stopping care. METHODS: We evaluated adults starting ART over 2.5 years in 14 clinics in Uganda, Tanzania, and Kenya. We traced a random sample of patients lost to follow-up and incorporated updated information in weighted competing risks estimates of retention. Reasons for nonreturn were surveyed. RESULTS: Among 18 081 patients, 3150 (18%) were lost to follow-up and 579 (18%) were traced. Of 497 (86%) with ascertained vital status, 340 (69%) were alive and, in 278 (82%) cases, updated care status was obtained. Among all patients initiating ART, weighted estimates incorporating tracing outcomes found that 2 years after ART, 69% were in care at their original clinic, 14% transferred (4% official and 10% unofficial), 6% were alive but out of care, 6% died in care (<60 days after last visit), and 6% died out of care (≥ 60 days after last visit). Among lost patients found in care elsewhere, structural barriers (eg, transportation) were most prevalent (65%), followed by clinic-based (eg, waiting times) (33%) and psychosocial (eg, stigma) (27%). Among patients not in care elsewhere, psychosocial barriers were most prevalent (76%), followed by structural (51%) and clinic based (15%). CONCLUSIONS: Accounting for outcomes among those lost to follow-up yields a more informative assessment of retention. Structural barriers contribute most to silent transfers, whereas psychological and social barriers tend to result in longer-term care discontinuation.

Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania.

We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes.

Prevalence of HIV and syphilis infections among pregnant women attending antenatal clinics in Tanzania, 2011.

BACKGROUND: The occurrence of HIV-1 and syphilis infections during pregnancy poses major health risks to the foetus due to mother-to-child transmission. We conducted surveillance of HIV and syphilis infections among pregnant women attending antenatal clinics (ANCs) in Mainland Tanzania in 2011. METHODS: This surveillance was carried out in 133 ANCs selected from 21 regions in Tanzania. In each region, six ANC sites were selected, with urban, semi-urban, and rural areas contributing two each. All pregnant women who were attending selected sentinel ANC sites for the first time at any pregnancy between September and December 2011 were enrolled. Serial ELISA assays were performed to detect HIV infection in an unlinked anonymous manner using dried blood spot (DBS) after routine syphilis testing. Data analysis was conducted using Stata v.12 software. RESULTS: A total of 39,698 pregnant women representing 2.4 % of all pregnant women (1.68 million) attending ANCs in the Mainland Tanzania were enrolled. The overall HIV prevalence was found to be 5.6 % (95 % CI: 5.4-5.8 %). The risk for HIV infection was significantly higher among women aged 25-34 (cOR = 1.97, 95 % CI: 1.79-2.16; p < 0.05), older than 35 years (cOR = 1.88, 95 % CI: 1.62-2.17; p < 0.05) and those having 1-2 and 3-4 previous pregnancies. HIV infection was less prevalent among women attending rural ANC clinics (cOR = 0.46, 95 % CI 0.4-0.52; p < 0.05). The overall syphilis prevalence was 2.5 % (95 % CI: 2.3, 3.6). The risk for syphilis infection was significantly higher among women attending semi-urban and rural clinics and those having 3-4, and 5 previous pregnancies (p < 0.05). Marital status and level of education were not statistically significant with either of the two infections. HIV and syphilis co-infections occurred in 109 of 38,928 (0.3 %). CONCLUSION: The overall prevalence of HIV infection (5.6 %) and syphilis (2.5 %) found among pregnant women attending ANC clinics in Tanzania calls for further strengthening of current intervention measures, which include scaling up the integration of prevention of mother to child transmission (PMTCT) services in Reproductive and Child Health (RCH) clinics.

Monitoring prevention or emergence of HIV drug resistance: results of a population-based foundational survey of early warning indicators in mainland Tanzania.

BACKGROUND: In Tanzania, routine individual-level testing for HIV drug resistance (HIVDR) using laboratory genotyping and phenotyping is not feasible due to resource constraints. To monitor the prevention or emergence of HIVDR at a population level, WHO developed generic strategies to be adapted by countries, which include a set of early warning indicators (EWIs). METHODS: To establish a baseline of EWIs, we conducted a retrospective longitudinal survey of 35 purposively sampled care and treatment clinics in 17 regions of mainland Tanzania. We extracted data relevant for four EWIs (ART prescribing practices, patients lost to follow-up 12 months after ART initiation, retention on first-line ART at 12 months, and ART clinic appointment keeping in the first 12 months) from the patient monitoring system on patients who initiated ART at each respective facility in 2010. We uploaded patient information into WHO HIVResNet excel-based tool to compute national and facility averages of the EWIs and tested for associations between various programmatic factors and EWI performance using Fisher's Exact Test. RESULTS: All sampled facilities met the WHO EWI target (100%) for ART prescribing practices. However, the national averages for patients lost to follow-up 12 months after ART initiation, retention on first-line ART at 12 months, and ART clinic appointment keeping in the first 12 months fell short, at 26%, 54% and 38%, respectively, compared to the WHO targets ≤ 20%, ≥ 70%, and ≥ 80%. Clinics with fewer patients lost to follow-up 12 months after ART initiation and more patients retained on first-line-ART at 12 months were more likely to have their patients spend the longest time in the facility (including wait-time and time with providers), (p = 0.011 and 0.007, respectively). CONCLUSION: Tanzania performed very well in EWI 1a, ART prescribing practices. However, its performance in other three EWIs was far below the WHO targets. This study provides a baseline for future monitoring of EWIs in Tanzania and highlights areas for improvement in the management of ART patients in order not only to prevent emergence of HIVDR due to programmatic factors, but also to improve the quality of life for ART patients.

Changes in patterns of retention in HIV care and antiretroviral treatment in Tanzania between 2008 and 2016: an analysis of routinely collected national programme data.

BACKGROUND: Tanzania is a high HIV burden country in Sub-Saharan Africa with 1.5 million people infected. Unless monitored and responded to, low levels of retention in care may lead to poor HIV associated clinical outcomes and an increased likelihood of onward viral transmission. Using routine data, we assessed changes in retention in care and on treatment for HIV over time in Tanzanian facilities, using the national care and treatment programme (CTC) database. METHODS: Data were extracted from the CTC database and analysed using two approaches: a series of cross-sectional analyses for each calendar year between 2008 and 2016 to assess the changing characteristics of the population in care and on treatment, and, a longitudinal analysis using survival analysis methods for a series of cohorts representing i) all engaging in care and ii) all initiating treatment in each calendar year from 2008 to 2015. Multivariate analyses were carried out to explore the independent effect of calendar year when controlling for other factors. RESULTS: The total number of individuals enrolled in care increased from 160 268 in 2008 to 548 296 in 2016. The percentage of the in-care population enrolled for more than 3 years increased from 9.9% in 2008 to 54.5% in 2016. The overall rates of retention in care were 80.9%, 57.3% and 45.4% at 12, 24 and 36 months respectively. The rates of retention on antiretroviral therapy (ART) ART at 12, 24 and 36 months after treatment-initiation were 83.9%, 64.0% and 53.5%. There were small but statistically significant differences in the retention rates between cohorts and evidence for a significant decrease in the rates of retention in the most recent years analysed. CONCLUSIONS: Data from Tanzania show that while the number of People Living with HIV (PLHIV) who were in care and monitored through the routine data system increased over time, the retention rates in care and treatment remained relatively stable. These rates were similar to other regional estimates. Systematic reviews of tracing studies indicate that mortality among those lost to follow up has decreased over time, partly underpinned by an increase in the numbers transferring between clinics. True retention rates may therefore be higher than we report here, and this underpins the need for data systems that can track patients between clinics.

Characterizing a Leak in the HIV Care Cascade: Assessing Linkage Between HIV Testing and Care in Tanzania.

Background: In Tanzania, HIV testing data are reported aggregately for national surveillance, making it difficult to accurately measure the extent to which newly diagnosed persons are entering care, which is a critical step of the HIV care cascade. We assess, at the individual level, linkage of newly diagnosed persons to HIV care. Methods: An expanded two-part referral form was developed to include additional variables and unique identifiers. The expanded form contained a corresponding number for matching the two-parts between testing and care. Data were prospectively collected at 16 health facilities in the Magu District of Tanzania. Results: The records of 1,275 unique people testing HIV positive were identified and included in our analysis. Of these, 1,200 (94.1%) responded on previous testing history, with 184 (15.3%) testing twice or more during the pilot, or having had a previous HIV positive test. Three-quarters (932; 73.1%) of persons were linked to care during the pilot timeframe. Health service provision in the facility carrying out the HIV test was the most important factor for linkage to care; poor linkage occurred in facilities where HIV care was not immediately available. Conclusions: It is critical for persons newly diagnosed with HIV to be linked to care in a timely manner to maximize treatment effectiveness. Our findings show it is feasible to measure linkage to care using routinely collected data arising from an amended national HIV referral form. Our results illustrate the importance of utilizing individual-level data for measuring linkage to care, as repeat testing is common.

Implementation of "Treat-all" at adult HIV care and treatment sites in the Global IeDEA Consortium: results from the Site Assessment Survey.

INTRODUCTION: Since 2015, the World Health Organization (WHO) has recommended that all people living with HIV (PLHIV) initiate antiretroviral treatment (ART), irrespective of CD4+ count or clinical stage. National adoption of universal treatment has accelerated since WHO's 2015 "Treat All" recommendation; however, little is known about the translation of this guidance into practice. This study aimed to assess the status of Treat All implementation across regions, countries, and levels of the health care delivery system. METHODS: Between June and December 2017, 201/221 (91%) adult HIV treatment sites that participate in the global IeDEA research consortium completed a survey on capacity and practices related to HIV care. Located in 41 countries across seven geographic regions, sites provided information on the status and timing of site-level introduction of Treat All, as well as site-level practices related to ART initiation. RESULTS: Almost all sites (93%) reported that they had begun implementing Treat All, and there were no statistically significant differences in site-level Treat All introduction by health facility type, urban/rural location, sector (public/private) or country income level. The median time between national policy adoption and site-level introduction was one month. In countries where Treat All was not yet adopted in national guidelines, 69% of sites reported initiating all patients on ART, regardless of clinical criteria, and these sites had been implementing Treat All for a median period of seven months at the time of the survey. The majority of sites (77%) reported typically initiating patients on ART within 14 days of confirming diagnosis, with 60% to 62% of sites implementing Treat All in East, Southern and West Africa reporting same-day ART initiation for most patients. CONCLUSIONS: By mid- to late-2017, the Treat All strategy was the standard of care at almost all IeDEA sites, including rural, primary-level health facilities in low-resource settings. While further assessments of site-level capacity to provide high-quality HIV care under Treat All and to support sustained viral suppression after ART initiation are needed, the widespread introduction of Treat All at the service delivery level is a critical step towards global targets for ending the HIV epidemic as a public health threat.

Implementation and Operational Research: Declining Tuberculosis Incidence Among People Receiving HIV Care and Treatment Services in East Africa, 2007-2012.

BACKGROUND: Antiretroviral therapy (ART) reduces the risk of Tuberculosis (TB) among people living with HIV (PLWH). With ART scale-up in sub-Saharan Africa over the past decade, incidence of TB among PLWH engaged in HIV care is predicted to decline. METHODS: We conducted a retrospective analysis of routine clinical data from 168,330 PLWH receiving care at 35 facilities in Kenya, Tanzania, and Uganda during 2003-2012, participating in the East African region of the International Epidemiologic Databases to Evaluate AIDS. Temporal trends in facility-based annual TB incidence rates (per 100,000 person years) among PLWH and country-specific standardized TB incidence ratios using annual population-level TB incidence data from the World Health Organization were computed between 2007 and 2012. We examined patient-level and facility-level factors associated with incident TB using multivariable Cox models. RESULTS: Overall, TB incidence rates among PLWH in care declined 5-fold between 2007 and 2012 from 5960 to 985 per 100,000 person years [P = 0.0003] (Kenya: 7552 to 1115 [P = 0.0007]; Tanzania: 7153 to 635 [P = 0.0025]; Uganda: 3204 to 242 [P = 0.018]). Standardized TB incidence ratios significantly decreased in the 3 countries, indicating a narrowing gap between incidence rates among PLWH and the general population. We observed lower hazards of incident TB among PLWH on ART and/or isoniazid preventive therapy and receiving care in facilities offering TB treatment onsite. CONCLUSIONS: Annual TB incidence rates among PLWH significantly declined during ART scale-up but remained higher than the general population. Increasing access to ART and isoniazid preventive therapy and co-location of HIV and TB treatment may further reduce TB incidence among PLWH.

Patient-reported factors associated with reengagement among HIV-infected patients disengaged from care in East Africa.

OBJECTIVE: Engagement in care is key to successful HIV treatment in resource-limited settings; yet little is known about the magnitude and determinants of reengagement among patients out of care. We assessed patient-reported reasons for not returning to clinic, identified latent variables underlying these reasons, and examined their influence on subsequent care reengagement. DESIGN: We used data from the East Africa International Epidemiologic Databases to Evaluate AIDS to identify a cohort of patients disengaged from care (>3 months late for last appointment, reporting no HIV care in preceding 3 months) (n = 430) who were interviewed about reasons why they stopped care. Among the 399 patients for whom follow-up data were available, 104 returned to clinic within a median observation time of 273 days (interquartile range: 165-325). METHODS: We conducted exploratory and confirmatory factor analyses (EFA, CFA) to identify latent variables underlying patient-reported reasons, then used these factors as predictors of time to clinic return in adjusted Cox regression models. RESULTS: EFA and CFA findings suggested a six-factor structure that lent coherence to the range of barriers and motivations underlying care disengagement, including poverty, transport costs, and interference with work responsibilities; health system 'failures,' including poor treatment by providers; fearing disclosure of HIV status; feeling healthy; and treatment fatigue/seeking spiritual alternatives to medicine. Factors related to poverty and poor treatment predicted higher rate of return to clinic, whereas the treatment fatigue factor was suggestive of a reduced rate of return. CONCLUSION: Certain barriers to reengagement appear easier to overcome than factors such as treatment fatigue. Further research will be needed to identify the easiest, least expensive interventions to reengage patients lost to HIV care systems. Interpersonal interventions may continue to play an important role in addressing psychological barriers to retention.

Facility-Level Factors Influencing Retention of Patients in HIV Care in East Africa.

Losses to follow-up (LTFU) remain an important programmatic challenge. While numerous patient-level factors have been associated with LTFU, less is known about facility-level factors. Data from the East African International epidemiologic Databases to Evaluate AIDS (EA-IeDEA) Consortium was used to identify facility-level factors associated with LTFU in Kenya, Tanzania and Uganda. Patients were defined as LTFU if they had no visit within 12 months of the study endpoint for pre-ART patients or 6 months for patients on ART. Adjusting for patient factors, shared frailty proportional hazard models were used to identify the facility-level factors associated with LTFU for the pre- and post-ART periods. Data from 77,362 patients and 29 facilities were analyzed. Median age at enrolment was 36.0 years (Interquartile Range: 30.1, 43.1), 63.9% were women and 58.3% initiated ART. Rates (95% Confidence Interval) of LTFU were 25.1 (24.7-25.6) and 16.7 (16.3-17.2) per 100 person-years in the pre-ART and post-ART periods, respectively. Facility-level factors associated with increased LTFU included secondary-level care, HIV RNA PCR turnaround time >14 days, and no onsite availability of CD4 testing. Increased LTFU was also observed when no nutritional supplements were provided (pre-ART only), when TB patients were treated within the HIV program (pre-ART only), and when the facility was open ≤4 mornings per week (ART only). Our findings suggest that facility-based strategies such as point of care laboratory testing and separate clinic spaces for TB patients may improve retention.

Estimation of mortality among HIV-infected people on antiretroviral treatment in East Africa: a sampling based approach in an observational, multisite, cohort study.

BACKGROUND: Mortality in HIV-infected people after initiation of antiretroviral treatment (ART) in resource-limited settings is an important measure of the effectiveness and comparative effectiveness of the global public health response. Substantial loss to follow-up precludes accurate accounting of deaths and limits our understanding of effectiveness. We aimed to provide a better understanding of mortality at scale and, by extension, the effectiveness and comparative effectiveness of public health ART treatment in east Africa. METHODS: In 14 clinics in five settings in Kenya, Uganda, and Tanzania, we intensively traced a sample of patients randomly selected using a random number generator, who were infected with HIV and on ART and who were lost to follow-up (>90 days late for last scheduled visit). We incorporated the vital status outcomes for these patients into analyses of the entire clinic population through probability-weighted survival analyses. FINDINGS: We followed 34 277 adults on ART from Mbarara and Kampala in Uganda, Eldoret, and Kisumu in Kenya, and Morogoro in Tanzania. The median age was 35 years (IQR 30-42), 11 628 (34%) were men, and median CD4 count count before therapy was 154 cells per µL (IQR 70-234). 5780 patients (17%) were lost to follow-up, 991 (17%) were selected for tracing between June 10, 2011, and Aug 27, 2012, and vital status was ascertained for 860 (87%). With incorporation of outcomes from the patients lost to follow-up, estimated 3 year mortality increased from 3·9% (95% CI 3·6-4·2) to 12·5% (11·8-13·3). The sample-corrected, unadjusted 3 year mortality across settings was lowest in Mbarara (7·2%) and highest in Morogoro (23·6%). After adjustment for age, sex, CD4 count before therapy, and WHO stage, the sample-corrected hazard ratio comparing the settings with highest and lowest mortalities was 2·2 (95% CI 1·5-3·4) and the risk difference for death at 3 years was 11% (95% CI 5·0-17·7). INTERPRETATION: A sampling-based approach is widely feasible and important to an understanding of mortality after initiation of ART. After adjustment for measured biological drivers, mortality differs substantially across settings despite delivery of a similar clinical package of treatment. Implementation research to understand the systems, community, and patients' behaviours driving these differences is urgently needed. FUNDING: The US National Institutes of Health and President's Emergency Fund for AIDS Relief.

HIV prevention in care and treatment settings: baseline risk behaviors among HIV patients in Kenya, Namibia, and Tanzania.

UNLABELLED: HIV care and treatment settings provide an opportunity to reach people living with HIV/AIDS (PLHIV) with prevention messages and services. Population-based surveys in sub-Saharan Africa have identified HIV risk behaviors among PLHIV, yet data are limited regarding HIV risk behaviors of PLHIV in clinical care. This paper describes the baseline sociodemographic, HIV transmission risk behaviors, and clinical data of a study evaluating an HIV prevention intervention package for HIV care and treatment clinics in Africa. The study was a longitudinal group-randomized trial in 9 intervention clinics and 9 comparison clinics in Kenya, Namibia, and Tanzania (N = 3538). Baseline participants were mostly female, married, had less than a primary education, and were relatively recently diagnosed with HIV. Fifty-two percent of participants had a partner of negative or unknown status, 24% were not using condoms consistently, and 11% reported STI symptoms in the last 6 months. There were differences in demographic and HIV transmission risk variables by country, indicating the need to consider local context in designing studies and using caution when generalizing findings across African countries. Baseline data from this study indicate that participants were often engaging in HIV transmission risk behaviors, which supports the need for prevention with PLHIV (PwP). TRIAL REGISTRATION: ClinicalTrials.gov NCT01256463.

Evaluating the systems used to monitor HIV populations accessing therapy and care in low-income and lower-middle-income countries.

OBJECTIVES: The scale-up of delivery of antiretroviral therapy (ART) in low-income and middle-income countries has been coupled with the collection of data aimed at monitoring the welfare of the HIV-positive and treated populations in those countries. We aimed to compare the data items collected and reported and the degree of harmonization achieved following the publication of WHO tools for collection and reporting of these data in 2006, and of two United Nations General Assembly Special Session (UNGASS) indicators relating to the health of patients on ART in 2008. DESIGN: Retrospective examination of monitoring tools used in four countries in 2008 and 2010. METHODS: We examined and compared the type of information collected and reported from treatment and care programmes in Malawi, Uganda, Tanzania and Ukraine. We also assessed the effect of the publication of the WHO-recommended data capture and reporting tools and the UNGASS-recommended indicators on harmonizing data in these four countries 2 years following the publication of each of these tools and indicators. RESULTS: : Although the majority of WHO-recommended data items were included in patient record cards, clinic ART registers and in reports submitted to the ministries of health in the countries by 2010, there remains little concordance between the four countries examined on the specific items included in patient records and monitoring reports. Furthermore, numerous additional items, which differ by country, and which are not included in WHO recommendations, are still recorded and reported. CONCLUSION: The differences and diversity of data reported across countries continues to challenge our ability to make international comparisons and to assess programme performance.