Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

INTRODUCTION: The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. METHODS: The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. RESULTS: Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. CONCLUSIONS: Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa

Factors associated with uptake of home-based HIV counselling and testing and HIV care services among identified HIV-positive persons in Masaka, Uganda.

We investigated uptake of home-based HIV counselling and testing (HBHCT) and HIV care services post-HBHCT in order to inform the design of future HBHCT programmes. We used data from an open-label cluster-randomised controlled trial which had demonstrated the effectiveness of a post-HBHCT counselling intervention in increasing linkage to HIV care. HBHCT was offered to adults (≥18 years) from 28 rural communities in Masaka, Uganda; consenting HIV-positive care naïve individuals were enrolled and referred for care. The trial's primary outcome was linkage to HIV care (clinic-verified registration for care) six months post-HBHCT. Random effects logistic regression was used to investigate factors associated with HBHCT uptake, linkage to care, CD4 count receipt, and antiretroviral therapy (ART) initiation; all analyses of uptake of post-HBHCT services were adjusted for trial arm allocation. Of 13,455 adults offered HBHCT, 12,100 (89.9%) accepted. HBHCT uptake was higher among men [adjusted odds ratio (aOR) 1.20, 95% confidence interval (CI) = 1.07-1.36] than women, and decreased with increasing age. Of 551 (4.6%) persons who tested HIV-positive, 205 (37.2%) were in care. Of those not in care, 302 (87.3%) were enrolled in the trial and of these, 42.1% linked to care, 35.4% received CD4 counts, and 29.8% initiated ART at 6 months post-HBHCT. None of the investigated factors was associated with linkage to care. CD4 count receipt was lower in individuals who lived ≥30 min from an HIV clinic (aOR 0.60, 95%CI = 0.34-1.06) versus those who lived closer. ART initiation was higher in older individuals (≥45 years versus <25 years, aOR 2.14, 95% CI = 0.98-4.65), and lower in single (aOR 0.60, 95% CI = 0.28-1.31) or divorced/separated/widowed (aOR 0.47, 95% CI = 0.23-0.93) individuals versus those married/cohabiting. HBHCT was highly acceptable but uptake of post-HBHCT care was low. Other than post-HBHCT counselling, this study did not identify specific issues that require addressing to further improve linkage to care

Assessing water filtration and safe storage in households with young children of HIV-positive mothers: a randomized, controlled trial in Zambia.

BACKGROUND: Unsafe drinking water presents a particular threat to people living with HIV/AIDS (PLHIV) due to the increased risk of opportunistic infections, diarrhea-associated malabsorption of essential nutrients, and increased exposure to untreated water for children of HIV-positive mothers who use replacement feeding to reduce the risk of HIV transmission. This population may particularly benefit from an intervention to improve water quality in the home. METHODS AND FINDINGS: We conducted a 12-month randomized, controlled field trial in Zambia among 120 households with children <2 years (100 with HIV-positive mothers and 20 with HIV-negative mothers to reduce stigma of participation) to assess a high-performance water filter and jerry cans for safe storage. Households were followed up monthly to assess use, drinking water quality (thermotolerant coliforms (TTC), an indicator of fecal contamination) and reported diarrhea (7-day recall) among children <2 years and all members of the household. Because previous attempts to blind the filter have been unsuccessful, we also assessed weight-for-age Z-scores (WAZ) as an objective measure of diarrhea impact. Filter use was high, with 96% (596/620) of household visits meeting the criteria for users. The quality of water stored in intervention households was significantly better than in control households (3 vs. 181 TTC/100 mL, respectively, p<0.001). The intervention was associated with reductions in the longitudinal prevalence of reported diarrhea of 53% among children <2 years (LPR=0.47, 95% CI: 0.30-0.73, p=0.001) and 54% among all household members (LPR=0.46, 95% CI: 0.30-0.70, p<0.001). While reduced WAZ was associated with reported diarrhea (-0.26; 95% CI: -0.37 to -0.14, p<0.001), there was no difference in WAZ between intervention and control groups. CONCLUSION: In this population living with HIV/AIDS, a water filter combined with safe storage was used correctly and consistently, was highly effective in improving drinking water quality, and was protective against diarrhea. TRIAL REGISTRATION: Clinicaltrials.gov NCT01116908

An open-label cluster randomised trial to evaluate the effectiveness of a counselling intervention on linkage to care among HIV-infected patients in Uganda: Study design.

INTRODUCTION: Home-based HIV counselling & testing (HBHCT) is highly acceptable and has the potential to increase HIV testing uptake in sub-Saharan Africa. However, data are lacking on strategies that can effectively link HIV-positive individuals identified through HBHCT to care. This trial was designed to assess the effectiveness of two brief home-based counselling sessions on linkage to care, provided subsequent to referral for care among HIV-positive patients identified through HBHCT in a rural community in Masaka district, Uganda. METHODS: 28 communities (clusters) were randomly allocated to control (referral only) and intervention (referral and follow-up counselling) arms (n = 14 clusters/arm). Randomisation was stratified on distance from the district capital (?10 km vs > 10 km) and cluster size (larger single village vs combined small villages), and restricted to ensure balance on selected cluster characteristics. A list of possible allocations was generated and one randomly selected at a public ceremony. HBHCT is being offered to all adults (?18 years), and HIV-positive individuals not yet in care are eligible for enrolment. The intervention is provided at one and two months post-enrolment. Primary outcomes, assessed 6 months after enrolment, are: the proportion of individuals linking to HIV care within 6 months of HIV diagnosis and time to linkage. The primary analysis will be based on individual-level data. DISCUSSION: This study will provide evidence on the impact of a counselling intervention on linkage to care among adults identified with HIV infection through HBHCT. Interpretation of the trial outcomes will be aided by results from an on-going qualitative sub-study

Sexual behaviour, changes in sexual behaviour and associated factors among women at high risk of HIV participating in feasibility studies for prevention trials in Tanzania.

INTRODUCTION: Risk reduction towards safer behaviour is promoted after enrolment in HIV prevention trials. We evaluated sexual behaviour, changes in sexual behaviour and factors associated with risky behaviour after one-year of follow-up among women enrolled in HIV prevention trials in Northern Tanzania. METHODS: Self-reported information from 1378 HIV-negative women aged 18-44 enrolled in microbicide and vaccine feasibility studies between 2008-2010,was used to assess changes in behaviour during a 12-month follow-up period. Logistic regression with random intercepts was used to estimate odds ratios for trends in each behaviour over time. A behavioural risk score was derived from coefficients of three behavioural variables in a Poisson regression model for HIV incidence and thereafter, dichotomized to risky vs less-risky behaviour. Logistic regression was then used to identify factors associated with risky behaviour at 12 months. RESULTS: At baseline, 22% reported multiple partners, 28% were involved in transactional sex and only 22% consistently used condoms with non-regular partners. The proportion of women reporting multiple partners, transactional sex and high-risk sex practices reduced at each 3-monthly visit (33%, 43% and 47% reduction in odds per visit respectively, p for linear trend <0.001 for all), however, there was no evidence of a change in the proportion of women consistently using condoms with non-regular partners (p = 0.22). Having riskier behaviours at baseline, being younger than 16 years at sexual debut, having multiple partners, selling sex and excessive alcohol intake at baseline were strongly associated with increased odds of risky sexual behaviour after 12 months (p<0.005 for all). CONCLUSION: An overall reduction in risky behaviours over time was observed in HIV prevention cohorts. Risk reduction counselling was associated with decreased risk behaviour but was insufficient to change behaviours of all those at highest risk. Biological HIV prevention interventions such as PrEP for individuals at highest risk, should complement risk reduction counselling so as to minimize HIV acquisition risk

Correction of estimates of retention in care among a cohort of HIV-positive patients in Uganda in the period before starting ART: a sampling-based approach.

OBJECTIVE: The aim of this study was to use a sampling-based approach to obtain estimates of retention in HIV care before initiation of antiretroviral treatment (ART), corrected for outcomes in patients who were lost according to clinic registers. DESIGN: Retrospective cohort study of HIV-positive individuals not yet eligible for ART (CD4 >500). SETTING: Three urban and three rural HIV care clinics in Uganda; information was extracted from the clinic registers for all patients who had registered for pre-ART care between January and August 2015. PARTICIPANTS: A random sample of patients who were lost according to the clinic registers (>3 months late to scheduled visit) was traced to ascertain their outcomes. OUTCOME MEASURES: The proportion of patients lost from care was estimated using a competing risks approach, first based on the information in the clinic records alone and then using inverse probability weights to incorporate the results from tracing. Cox regression was used to determine factors associated with loss from care. RESULTS: Of 1153 patients registered for pre-ART care (68% women, median age 29 years, median CD4 count 645 cells/µL), 307 (27%) were lost according to clinic records. Among these, 195 (63%) were selected for tracing; outcomes were ascertained in 118 (61%). Seven patients (6%) had died, 40 (34%) were in care elsewhere and 71 (60%) were out of care. Loss from care at 9 months was 30.2% (95% CI 27.3% to 33.5%). After incorporating outcomes from tracing, loss from care decreased to 18.5% (95% CI 13.8% to 23.6%). CONCLUSION: Estimates of loss from HIV care may be too high if based on routine clinic data alone. A sampling-based approach is a feasible way of obtaining more accurate estimates of retention, accounting for transfers to other clinics

A prospective study of trends in consumption of cigarettes and alcohol among adults in a rural Ugandan population cohort, 1994-2011

OBJECTIVES: To characterise trends over time in smoking and alcohol consumption in a rural Ugandan population between 1994 and 2011. METHODS: We used self-reported data from a long-standing population cohort - the General Population Cohort. From 1989-1999, the study population comprised about 10,000 residents of 15 adjacent villages. From 1999, 10 more villages were added, doubling the population. Among adults (≥13 years, who comprise about half of the total study population) data on smoking were collected in 1994/95, 2008/9 and in 2010/11. Data on alcohol were collected in 1996/1997, 2000/2001, 2009/2010 and 2010/2011. RESULTS: The reported prevalence of smoking among men was 17% in 1994/1995, 14% in 2008/2009 and 16% in 2010/2011; equivalent figures for women were 1.5%, 1% and 2%. In the most recent time period, for both sexes combined, prevalence of smoking increased from 1.5% in those aged <29 years, to 18% in those 50+ years (P<0.001); prevalence was 14.8% in the lowest tertile of socio-economic status, decreasing to 3.7% in the highest (P<0.001). For alcohol consumption, current drinking was reported by 39% in 1996/1997, 35% in 2000/2001 and 28% in 2010/2011; men were more likely to drink than women (32.9% vs. 23.5% in 2010/2011) and consumption increased with age (P<0.001); was associated with low socio-economic status, riskier sexual behaviour and being HIV positive (P<0.001). CONCLUSION: In this rural Ugandan population, consumption of cigarettes and alcohol is higher among men than women, increases with age and is more frequent among those with low socio-economic status. We find no evidence of increases in either exposure over time. This article is protected by copyright. All rights reserved

The impact of a human papillomavirus (HPV) vaccination campaign on routine primary health service provision and health workers in Tanzania: a controlled before and after study.

BACKGROUND: The burden of cervical cancer and shortage of screening services in Tanzania confers an urgent need for human papillomavirus (HPV) vaccination. However, the sustainability and impact of another new vaccine campaign in an under-resourced health system requires consideration. We aimed to determine the impact of the government's school-based HPV vaccine campaign in Kilimanjaro region on the provision of routine primary health services and staff workload. METHODS: Data on daily numbers of consultations were collected from health facility register books in 63 dispensaries and health centres in North-West Tanzania for 20 weeks in 2014. Changes in outpatient, antenatal care (ANC), family planning (FP) and immunisation service activity levels before, during and after the two HPV vaccination campaigns in 2014 in 30 facilities within Kilimanjaro region ('intervention facilities') were compared with changes in activity levels in 33 facilities in Arusha region ('controls'). Qualitative interviews were conducted with health workers in Kilimanjaro region who delivered HPV vaccination and those who remained at the facility during in-school HPV vaccine delivery to explore perceptions of workload and capacity. RESULTS: Health facility activity levels were low and very variable in both regions. Controlling for district, facility type, catchment population, clinical staff per 1000 catchment population and the timing of other campaigns, no evidence of a decrease in consultations at the health facility during HPV vaccination week was found across outpatient, ANC, routine immunisation and FP services. However, compared to the average week before and after the campaign, health workers reported longer working hours and patient waiting times, feeling over-stretched and performing duties outside their normal roles whilst colleagues were absent from the facility conducting the HPV vaccine campaign. CONCLUSION: Qualitative interviews with health workers revealed that staff absence from the health facility is common for a number of reasons, including vaccination campaigns. Health workers perceived that the absence of their colleagues increased the workload at the health facility. The numbers of consultations for each service on 'normal days' were low and highly variable and there was no clear detrimental effect of the HPV vaccination campaign on routine health service activity

Relaxing the independent censoring assumption in the Cox proportional hazards model using multiple imputation.

The Cox proportional hazards model is frequently used in medical statistics. The standard methods for fitting this model rely on the assumption of independent censoring. Although this is sometimes plausible, we often wish to explore how robust our inferences are as this untestable assumption is relaxed. We describe how this can be carried out in a way that makes the assumptions accessible to all those involved in a research project. Estimation proceeds via multiple imputation, where censored failure times are imputed under user-specified departures from independent censoring. A novel aspect of our method is the use of bootstrapping to generate proper imputations from the Cox model. We illustrate our approach using data from an HIV-prevention trial and discuss how it can be readily adapted and applied in other settings

Adverse pregnancy outcomes in rural Uganda (1996-2013): trends and associated factors from serial cross sectional surveys.

OBJECTIVE: Community based evidence on pregnancy outcomes in rural Africa is lacking yet it is needed to guide maternal and child health interventions. We estimated and compared adverse pregnancy outcomes and associated factors in rural south-western Uganda using two survey methods. METHODS: Within a general population cohort, between 1996 and 2013, women aged 15-49 years were interviewed on their pregnancy outcome in the past 12 months (method 1). During 2012-13, women in the same cohort were interviewed on their lifetime experience of pregnancy outcomes (method 2). Adverse pregnancy outcome was defined as abortions or stillbirths. We used random effects logistic regression for method 1 and negative binomial regression with robust clustered standard errors for method 2 to explore factors associated with adverse outcome. RESULTS: One third of women reported an adverse pregnancy outcome; 10.8% (abortion = 8.4%, stillbirth = 2.4%) by method 1 and 8.5% (abortion = 7.2%, stillbirth = 1.3%) by method 2. Abortion rates were similar (10.8 vs 10.5) per 1000 women and stillbirth rates differed (26.2 vs 13.8) per 1000 births by methods 1 and 2 respectively. Abortion risk increased with age of mother, non-attendance of antenatal care and proximity to the road. Lifetime stillbirth risk increased with age. Abortion and stillbirth risk reduced with increasing parity. DISCUSSION: Both methods had a high level of agreement in estimating abortion rate but were markedly below national estimates. Stillbirth rate estimated by method 1 was double that estimated by method 2 but method 1 estimate was more consistent with the national estimates. CONCLUSION: Strategies to improve prospective community level data collection to reduce reporting biases are needed to guide maternal health interventions