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

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

Voluntary medical male circumcision for HIV prevention in fishing communities in Uganda: the influence of local beliefs and practice.

Local beliefs and practices about voluntary medical male circumcision (VMMC) may influence uptake and effectiveness. Data were gathered through interviews with 40 people from four ethnically mixed fishing communities in Uganda. Some men believed that wound healing could be promoted by contact with vaginal fluids while sex with non-regular partners could chase away spirits - practices which encouraged unsafe sexual practices. Information given by providers stressed that VMMC did not afford complete protection from sexually-transmitted infections, however, a number of male community members held the view that they were fully protected once circumcised. Both men and women said that VMMC was good not just for HIV prevention but also as a way of maintaining hygiene among the men. The implementation of VMMC in high-HIV prevalence settings needs to take account of local beliefs about circumcision, working with local religious/social group leaders, women and peers in the roll-out of the intervention

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

Feasibility of using smartphones by village health workers for pregnancy registration and effectiveness of mobile phone text messages on reduction of homebirths in rural Uganda

INTRODUCTION: Homebirths are common in low and middle income countries and are associated with poor child survival. We assessed the feasibility of using smartphones by village health workers for pregnancy registration and the effectiveness of health text messages (SMS) sent to pregnant women through village health workers in reducing homebirths in rural Uganda. METHODS: A non-randomised intervention study was undertaken in 26 villages. In the intervention arm, village health workers registered pregnant women (n = 262) in 13 villages using a smartphone app (doForm) and paper forms and gestation age-timed SMS were sent through village health workers to the pregnant women. In 13 control villages, (n = 263) pregnant women were registered on paper forms only and no SMS was sent. The main outcome was place of birth measured through a self-report. Logistic regression with generalised estimating equations was used to explore the effect of the intervention. RESULTS: Comparing 795 corresponding data fields on phone and paper revealed that numeric variable fields were 86%-95% similar while text fields were 38%-48% similar. Of the 525 pregnant women followed, 83 (15.8%) delivered at home. In the adjusted analysis, the intervention was associated with lower odds of homebirths [AOR = 0.38, 95%CI (0.15-0.97)]. Muslim religion [AOR = 4.0, 95%CI (1.72-9.34)], primary or no maternal education [AOR = 2.51, 95%CI (1.00-6.35)] and health facility distance ≥ 2 km [AOR = 2.26, 95%CI (0.95-5.40)] were independently associated with homebirths. CONCLUSION: Village health workers can register pregnant women at home using phones and relay gestation age specific SMS to them to effectively reduce homebirths

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

The impact of antiretroviral therapy on symptom burden among HIV outpatients with low CD4 count in rural Uganda: nested longitudinal cohort study.

BACKGROUND: Individuals with HIV have a high prevalence of physical and psychological symptoms throughout their disease course. Despite the clinical and public health implications of unresolved pain and symptoms, little is known about the effect of anti-retroviral therapy (ART) on these outcomes. This study aimed to assess the impact on symptom burden for the year after ART initiation in individuals with a CD4 count <200 cells/uL in Uganda. METHODS: HIV-infected, ART-naıve adults referred from voluntary testing and counseling services in rural Uganda for enrollment into a randomized controlled trial to test fluconazole as primary prophylaxis against cryptococcal disease were invited to complete the Memorial Symptom Assessment Scale-Short Form (MSAS-SF) prior to commencing ART and at two subsequent follow up visits. This tool measures self-reported 7-day period prevalence and associated burden of physical and psychological symptoms. Changes in the total number of symptoms and distress indices with time on ART and trial arm were investigated through fitting Linear Mixed Models for repeated measures. RESULTS: During the first year of ART initiation the prevalence of most individual symptoms remained constant. The notable exceptions which improved after commencing ART are as follow; prevalence of pain (prevalence changed from 79% to 60%), weight loss (67% to 31%), lack of appetite (46% to 28%), feeling sad (52% to 25%) and difficulty sleeping (35% to 23%). The total number of symptoms and distress indices reduced after treatment commenced. Of concern was that half or more study participants remained with symptoms of pain (60%), itching (57%), skin changes (53%) and numbness in hands and feet (52%) after starting ART. Sixteen symptoms remained with a burden of 25% or more. CONCLUSION: Despite the beneficial effect of ART on reducing symptoms, some patients continue to experience a high symptom burden. It is essential that HIV services in sub-Saharan Africa integrate management of symptoms into their programmes. TRIAL REGISTRATION: CRYPTOPRO [ISRCTN 76481529 ], November 2004

Feasibility of establishing an HIV vaccine preparedness cohort in a population of the Uganda Police Force: Lessons learnt from a prospective study.

BACKGROUND: Members of uniformed armed forces are considered to be at high risk for HIV infection and have been proposed as suitable candidates for participation in HIV intervention studies. We report on the feasibility of recruitment and follow up of individuals from the community of the Uganda Police Force (UPF) for an HIV vaccine preparedness study. METHODS: HIV-negative volunteers aged 18-49 years, were identified from UPF facilities situated in Kampala and Wakiso districts through community HIV counselling and testing. Potential volunteers were referred to the study clinic for screening, enrolment and quarterly visits for one year. HIV incidence, retention rates were estimated and expressed as cases per 100 person years of observation (PYO). Rate ratios were used to determine factors associated with retention using Poisson regression models. RESULTS: We screened 560 to enroll 500 volunteers between November 2015 and May 2016. One HIV seroconversion occurred among 431 PYO, for an incidence rate of 0.23/100 PYO (95% confidence interval [CI]: 0.03-1.64). Overall, retention rate was 87% at one year, and this was independently associated with residence duration (compared to 5 years aRR = 1.34, 95%CI: 0.95-1.37); absence of genital discharge in the last 3 months (aRR = 1.97, 95% CI: 1.38-2.83, absence of genital ulcers (aRR = 1.90, 95%CI: 1.26-2.87, reporting of new sexual partner in the last month (aRR = 0.57, 95%CI: 0.45-0.71, being away from home for more than two nights (aRR = 1.27, 95%CI: 1.04-1.56, compared to those who had not travelled) and absence of knowledge on HIV prevention (aRR = 2.67, 95%CI: 1.62-4.39). CONCLUSIONS: While our study demonstrates the feasibility of recruiting and retaining individuals from the UPF for HIV research, we did observe lower than anticipated HIV incidence, perhaps because individuals at lower risk of HIV infection may have been the first to come forward to participate or participants followed HIV risk reduction measures. Our findings suggest lessons for recruitment of populations at high risk of HIV infection

Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda.

BACKGROUND: Use of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda. METHODS: HIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake. RESULTS: A total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26-38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7-3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method. CONCLUSION: Promotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product. TRIAL REGISTRATION: Protocol Number ISRCTN64716212