Low proportion of women who came knowing their HIV status at first antenatal care visit, Uganda, 2012-2016: a descriptive analysis of surveillance data.

BACKGROUND: HIV testing is the cornerstone for HIV care and support services, including Prevention of Mother to Child Transmission of HIV (PMTCT). Knowledge of HIV status is associated with better reproductive health choices and outcomes for the infant's HIV status. We analyzed trends in known current HIV status among pregnant women attending the first antenatal care (ANC) visit in Uganda, 2012-2016. METHODS: We conducted secondary data analysis using District Health Information Software2 data on all pregnant women who came for ANC visit during 2012-2016. Women who brought documented HIV negative test result within the previous 4 weeks at the first ANC visit or an HIV positive test result and/or own HIV care card were considered as knowing their HIV status. We calculated proportions of women with known current HIV status at first ANC visit, and described linear trends both nationally and regionally. We tested statistical significance of the trend using modified Poisson regression with generalized linear models. For known HIV positive status, we only analyzed data for years 2015-2016 because this is when this data became available. RESULTS: There was no significant difference in the number of women that attended first ANC visits over years 2012-2016. The proportion of women that came with known HIV status increased from 4.4% in 2012 to 6.9% in 2016 and this increase was statistically significant (p < 0.001). Most regions had an increase in trend except the West Nile and Mid-Eastern (p < 0.001). The proportion of women that came knowing their HIV positive status at first ANC visit was slightly higher than that of women that were newly tested HIV positive at first ANC visit in 2015 and 2016. CONCLUSION: Although the gap in women that come at first ANC visit without knowing their HIV positive status might be reducing, a large proportion of women who were infected with HIV did not know their status before the first ANC visit indicating a major public health gap. We recommend advocacy for early ANC attendance and hence timely HIV testing and innovations to promptly identify HIV positive women of reproductive age so that timely PMTCT interventions can be made.

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.

BACKGROUND: HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. METHODS AND FINDINGS: We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29-1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08-1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. CONCLUSIONS: In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. TRIAL REGISTRATION: ClinicalTrials.gov NCT02846402.

Risk Screening Tools Could Potentially Miss HIV-Positive Individuals Who Seek Testing Services: A Secondary Program Data Analysis on the Performance Characteristics of an Adolescent and Adult HIV Risk Screening Tool in Uganda.

Improving HIV testing efficiency saves financial and material resources for health. We conducted a secondary data analysis of routinely collected HIV risk-screening program data in Uganda, from October to November 2019, to determine the performance characteristics of the adolescent and adult HIV risk screening tools in public health facilities. A total of 19,854 clients had been screened for HIV testing eligibility and tested for HIV. The overall positivity rate (cluster-weighted prevalence of HIV) among those screened was 4.5% (95% CI: 4.1-4.8) versus 3.71% (95% CI: 3.06-4.50) among those not screened. The sensitivity and specificity of the risk screening tool were 91% (95% CI: 89-93) and 25% (24.2-26), respectively. With screening, the number needed to test to identify one PLHIV was reduced from 27 to 22. Although risk screening would have led to a 24.5% (4825/19,704) reduction in testing volume, 9.3% (68/732) of PLHIV would have been missed and be misclassified as not eligible for testing. The cost saving per PLHIV identified was minimally reduced by 3% from USD 69 without screening to USD 66.9 with screening. Since the treatment-adjusted prevalence of HIV is dropping globally, overzealous use of risk screening tools to determine who to test or not carries the potential of missing PLHIV due to their limited specificity. We recommend the use of scientifically validated HIV risk screening tools, and a need to explore the use of HIV self-testing as a test for tirage to minimize misclassification of people who seek HIV testing services.

Secondary distribution of HIV self-test kits from males to their female sexual partners in two fishing communities in rural Uganda.

Secondary distribution of HIV self-test kits from females to their male partners has increased HIV testing rates in men but little evidence exists on the potential for HIV self-test kits distribution from males to their female partners. We assessed the acceptability of secondary HIV self-test kits distribution from males to their female sexual partners in a fishing community context. This secondary analysis used data from the PEer-led HIV Self-Testing intervention for MEN (PEST4MEN), a pilot interventional study in Buvuma and Kalangala districts in Uganda. At the baseline visit, in July 2022, data were collected from 400 men aged 15+ years who self-reported a HIV-negative or unknown HIV status. Enrolled men were asked to pick two oral fluid HIV self-test kits from a trained male distributor. At the first follow-up visit, in September 2022, men were asked about the number of kits that they received and if they gave kits to anyone, including to their female sexual partners. We used a modified Poisson regression model to determine the factors independently associated with giving kits to sexual partners. Data were analyzed using STATA version 16.0. Of 361 men interviewed at follow-up, 98.3% (355) received at least one kit; 79.7% (283) received two kits. Of those who received two kits, 64% (181) gave the second kit to anyone else; of these, 74.6% (132/177) gave it to a sexual partner. Being currently married (adjusted prevalence ratio [adj. PR] = 1.39; 95% confidence interval [95%CI]: 1.10, 1.75) and having difficulty in reading text prepared in the local language (adj. PR = 1.26; 95%CI: 1.03, 1.55) were significantly associated with men giving kits to their female sexual partners. Ninety-seven per cent (112/132) of the men reported that they knew their sexual partners' HIV self-test results. Of these, 93.7% (n = 105) reported that their partners were HIV-negative while 6.3% (n = 7) reported that they were HIV-positive. Only 28.6% (n = 2) of the HIV-positive sexual partners were reported to have initiated HIV care. Secondary distribution of HIV self-test kits from males to their female sexual partners is well accepted by women in the fishing communities, suggesting that distribution of kits through men in the fishing communities can help to improve HIV testing uptake among their female sexual partners.

Factors Associated with Linkage to HIV Care Among Oral Self-Tested HIV Positive Adults in Uganda.

BACKGROUND: HIV oral self-testing (HIVST) was rolled out in Uganda in 2018. However, data reported by public facilities show that less than 60% of oral self-tested HIV positive adults were linked to HIV care. This study set out to determine the factors associated with linkage to HIV care among adults with positive HIV oral self-test results in Uganda. METHODS: A cross-sectional study was carried out at Nabweru HCIII and Entebbe Hospital in central Uganda. The study reviewed medical records from January 2019 to May 2020 and successfully invited 144 self-tested HIV positive participants for the quantitative interview process. Data on socio-demographics and health-related characteristics were collected. Bivariate and multivariable analysis was used to determine the factors associated with linkage to care. RESULTS: The proportion of participants linked to HIV care was 69.6% (100/144). The majority of the participants were female (71%), with a mean age of 29 (±8) years. Participants within age groups of 31-35 years and 41-60 years, who used directly assisted HIVST, disclosed their HIV status to their sexual partners, are ready to start ART, do not consume alcohol and having a supportive sexual partner were more likely to be linked to HIV care. Single participants, separated/divorced, female, fear unfair treatment after HIV status disclosure and those who fear ART side effects were less likely to be linked to HIV care. CONCLUSION: Our study showed that less than 70% were linked to HIV care. It also shows that HIV status disclosure, readiness to start ART, type of HIVST used, fear of ART side effects, and being divorced/separated negatively associated with linkage to HIV care among self-test HIV positive adults. There is a need for HIV programs to address the above factors to improve linkage to HIV care to realize the national targets towards the UNAIDs 2035 goals.

Stakeholders' perspectives on integrating the management of depression into routine HIV care in Uganda: qualitative findings from a feasibility study.

BACKGROUND: HIV/AIDS continues to be a major global public health problem with Eastern and Southern Africa being the regions most affected. With increased access to effective antiretroviral therapy, HIV has become a chronic and manageable disease, bringing to the fore issues of quality of life including mental wellbeing. Despite this, the majority of HIV care providers in sub-Saharan Africa, including Uganda's Ministry of Health, do not routinely provide mental health care including depression management. The purpose of this paper is to explore stakeholders' perspectives on the feasibility and acceptability of integrating depression management into routine adult HIV care. The paper addresses a specific objective of the formative phase of the HIV + D study aimed at developing and evaluating a model for integrating depression management into routine HIV care in Uganda. METHODS: This was a qualitative study. Data were collected through in-depth interviews with 11 patients at enrollment and follow-up in the pilot phase, and exit interviews with 11 adherent patients (those who completed their psychotherapy sessions) and six non-adherent patients (those missing at least two sessions) at the end of the pilot phase. Key informant interviews were held with four clinicians, five supervisors and one mental health specialist, as were three focus group discussions with lay health workers. These were purposively sampled at four public health facilities in Mpigi District. Data were analysed thematically. RESULTS: Patients highlighted the benefits of treating depression in the context of HIV care, including improved adherence to antiretroviral therapy, overcoming sleeplessness and suicidal ideation, and regaining a sense of self-efficacy. Although clinicians and other stakeholders reported benefits of treating depression, they cited challenges in managing depression with HIV care, which were organisational (increased workload) and patient related (extended waiting time and perceptions of preferential treatment). Stakeholders generally shared perspectives on how best to integrate, including recommendations for organisational level interventions-training, harmonisation in scheduling appointments and structural changes-and patient level interventions to enhance knowledge about depression. CONCLUSIONS: Integrating depression management into routine HIV care in Uganda is acceptable among key stakeholders, but the technical and operational feasibility of integration would require changes both at the organisational and patient levels.

Developing and Validating an Effective Pediatric and Adolescent HIV Testing Eligibility Screening Tool for High-Volume Entry Points in Uganda.

INTRODUCTION: Because of low pediatric HIV prevalence, more tests are needed to find 1 HIV-positive child compared with adults. In Uganda, the number needed to test (NNT) to find 1 new HIV-positive child was 64 in outpatient departments (OPDs) and 31 through index testing. We aimed to develop and validate a pediatric (1.5-14 years) screening tool to optimize testing approaches. METHODS: Phase 1 evaluated the performance of 10 screening questions in 14 OPDs using a variable selection algorithm to evaluate combinations of screening questions. Using logistic regression, we identified the number of screening questions with the best predictive accuracy using the receiver operation characteristic curve. Phase 2 validated the proposed tool in 15 OPDs and 7 orphan and vulnerable children programs. We estimated sensitivity, specificity, and NNT accounting for intercluster correlations. RESULTS: A total of 3482 children were enrolled. The optimal model included reported HIV-positive maternal status or 2/5 symptoms (sickly in the last 3 months, recurring skin problems, weight loss, not growing well, and history of tuberculosis). The proposed tool had sensitivity of 83.6% [95% confidence interval (CI): 68.1 to 92.4] and specificity of 62.5% (95% CI: 55.0 to 69.4). The tool was validated in a sample of 11,342 children; sensitivity was 87.8% (95% CI: 80.9 to 92.5) and specificity 62.6% (95% CI: 54.8 to 69.7) across OPDs and community sites. In OPDs, sensitivity was 88.1% (95% CI: 80.8 to 92.8) and specificity 69.0% (95% CI: 61.9 to 75.3). The NNT was 43 (95% CI: 28 to 67) across settings and 28 (95% CI: 20 to 38) for OPD. CONCLUSIONS: This HIV screening tool has high sensitivity and reasonable specificity, increasing testing efficiency and yield for children and adolescents.

Effectiveness and cost-effectiveness of integrating the management of depression into routine HIV Care in Uganda (the HIV + D trial): A protocol for a cluster-randomised trial.

BACKGROUND: An estimated 8-30 % of people living with HIV (PLWH) have depressive disorders (DD) in sub-Saharan Africa. Of these, the majority are untreated in most of HIV care services. There is evidence from low- and middle- income countries of the effectiveness of both psychological treatments and antidepressant medication for the treatment of DD among PLWH, but no evidence on how these can be integrated into routine HIV care. This protocol describes a cluster-randomised trial to evaluate the effectiveness and cost-effectiveness of the HIV + D model for the integration of a collaborative stepped care intervention for DD into routine HIV care, which we have developed and piloted in Uganda. METHODS: Forty public health care facilities that provide HIV care in Kalungu, Masaka and Wakiso Districts will be randomly selected to participate in the trial. Each facility will recruit 10-30 eligible PLWH with DD and the total sample size will be 1200. The clusters will be randomised 1:1 to receive Enhanced Usual Care alone (EUC, i.e. HIV clinicians trained in Mental Health Gap Action Programme including guidelines on when and where to refer patients for psychiatric care) or EUC plus HIV + D (psychoeducation, Behavioural Activation, antidepressant medication and referral to a supervising mental health worker, delivered in a collaborative care stepwise approach). Eligibility criteria are PLWH attending the clinic, aged ≥ 18 years who screen positive on a depression screening questionnaire (Patient Health Questionnaire, PHQ-9 ≥ 10). The primary outcome is the mean depressive disorder symptom severity scores (assessed using the PHQ-9) at 3 months' post-randomisation, with secondary mental health, disability, HIV and economic outcomes measured at 3 and 12 months. The cost-effectiveness of EUC with HIV + D will be assessed from both the health system and the societal perspectives by collecting health system, patient and productivity costs and mean DD severity scores at 3 months, additional to health and non-health related quality of life measures (EQ-5D-5 L and OxCAP-MH). DISCUSSION: The study findings will inform policy makers and practitioners on the cost-effectiveness of a stepped care approach to integrate depression management in routine care for PLWH in low-resource settings. TRIAL REGISTRATION: ISRCTN, ISRCTN86760765. Registered 07 September 2017, https://doi.org/10.1186/ISRCTN86760765 .

Costs of Providing HIV Self-Test Kits to Pregnant Women Living with HIV for Secondary Distribution to Male Partners in Uganda.

BACKGROUND: Secondary distribution of HIV self-testing kits (HIVST) to pregnant women attending antenatal care (ANC) clinics to give to their male partners is a promising strategy to increase testing coverage among men, but its costs are unknown. METHODS: We conducted micro-costing of a trial evaluating secondary distribution of HIVST on pregnant women living with HIV (PWLHIV) in an ANC in Kampala, Uganda. Costs (2019 USD) were collected from program budgets, expenditure records, time and motion observations, and staff interviews and estimated for three scenarios: as-studied, reflecting full costs of the research intervention, Ministry of Health (MOH) implementation, reflecting the research intervention if implemented by the MOH, and MOH roll-out, the current strategy being used to roll out HIVST distribution. RESULTS: In the as-studied scenario, cost of HIVST provision was $13.96/PWLHIV reached, and $11.89 and $10.55 per HIV-positive and HIV-negative male partner, respectively, who linked to a clinic for facility-based testing. In the MOH implementation scenario, costs were $9.45/PWLHIV, and $7.87 and $6.99, respectively, per HIV-positive and HIV-negative male partner linking to the clinic. In the MOH roll-out scenario, the cost of HIVST provision to pregnant women regardless of HIV status was $3.70/woman, and $6.65/HIV-positive male partner. CONCLUSION: Secondary distribution of HIVST from pregnant women can be implemented at reasonable cost to increase testing among men in Uganda and similar settings in Africa.

Active pediatric HIV case finding in Kenya and Uganda: A look at missed opportunities along the prevention of mother-to-child transmission of HIV (PMTCT) cascade.

BACKGROUND: Children living with HIV remain undiagnosed due to missed opportunities along the prevention of mother-to-child HIV transmission cascade. This study addresses programmatic gaps in the cascade by describing pregnancy and HIV-related services received by mothers of children newly identified as HIV-positive through active case finding. METHODS: This was a prospective observational cohort (2017-2018) of HIV-positive children <15 years of age newly diagnosed at study facilities and/or surrounding communities in Kenya and Uganda. At enrollment, caregivers were interviewed about maternal and child health and HIV history. Child medical and laboratory information was abstracted at two months post-diagnosis. Descriptive summary statistics were calculated; associations between selected factors and child age at HIV diagnosis were evaluated using generalized estimating equations. RESULTS: 174 HIV-positive children (median age 2.4 years) were enrolled. Among maternal caregivers, 110/132 (83.3%) attended antenatal care and 60 (45.5%) reported testing HIV-negative in antenatal care. Of 41 and 56 women known to be HIV-positive during pregnancy and breastfeeding respectively, 17 (41.5%) and 15 (26.8%) did not receive antiretroviral drugs. Despite known maternal HIV-positive status during pregnancy, 39% of these children were not diagnosed until after two years of age; children were diagnosed at younger ages in Uganda (p = 0.0074) and if mother was the caregiver (p<0.0001). The most common HIV testing points identifying children were outpatient (44.3%) and maternal/child health departments (29.9%). Nearly all children initiated antiretroviral therapy within two weeks of diagnosis. CONCLUSIONS: Multiple missed opportunities for HIV prevention and delays in HIV testing of HIV-exposed children were identified in newly diagnosed children. Findings support critical prevention messaging and retesting of HIV-negative women during pregnancy and breastfeeding, strengthening HIV treatment initiation and follow-up systems and interventions to ensure HIV-positive women receive lifelong antiretroviral therapy throughout the cascade, and broader implementation of community case finding so children not engaged in care receive testing services.

A pilot trial of the peer-based distribution of HIV self-test kits among fishermen in Bulisa, Uganda.

BACKGROUND: HIV self-testing (HIVST) addresses barriers to HIV diagnosis among men, but current approaches to distributing HIVST kits only reach a subset of the men requiring testing. METHODS: We conducted a pilot trial of the secondary distribution of HIVST kits through peer networks in fishing communities of Buliisa district (Uganda). We recruited distributors ("seeds") among male patients of a health facility, and among community members. Seeds were trained in HIVST and asked to distribute up to five kits to their peers ("recruits"). Recruits were referred to the study using a coupon, and asked to return the HIVST kit (used or unused). The accuracy of HIVST was measured against a confirmatory test conducted by a health worker. We conducted audio computer assisted self-interviews to measure the occurrence of adverse events, and evaluate the potential yield of peer-delivered HIVST. We also assessed how seeds and recruits rated their experience with peer-distributed HIVST. RESULTS: Nineteen seeds offered an HIVST kit to 116 men, and 95 (81.9%) accepted the offer. No recruit reported coercion, but two seeds experienced hostility from recruits or their family members. The sensitivity of peer-distributed HIVST, as interpreted by recruits, was 100%, and its specificity was 92.8%. Among recruits, 29 had never tested (25.8%), and 42 (44.2%) had tested more than a year ago. Three men living with HIV learned their status through peer-distributed HIVST (yield = 1 new diagnosis per 6.3 seeds). Most recruits (85/88) and seeds (19/19) reported that they would recommend HIVST to their friends and family. All seeds stated that they would accept acting as peer distributors again. CONCLUSIONS: This novel peer-based distribution model of HIVST is safe, and has high uptake. It could help reduce the gender gap in HIV testing in under-served fishing communities in Uganda and elsewhere.

HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study.

OBJECTIVE: To evaluate HIV self-testing performance and results interpretation among female sex workers (FSWs) in Kampala, Uganda, who performed unassisted HIV self-testing. METHODS: In October 2016, 104 participants used an oral HIV self-test while under observation by research assistants. Participants were not assisted on HIV self-test use prior to or during testing, and were only given the manufacturer's pictorial and written instructions to guide them. Research assistants recorded if participants completed and/or had difficulties with steps in the HIV self-testing process on a prespecified checklist. Randomly drawn, used HIV self-tests were interpreted by FSWs. We calculated the concordance between FSWs' interpretations of self-test results with those indicated in the manufacturer's instructions. RESULTS: Only 33% (34/104) of participants completed all of the key steps in the HIV self-testing process, and the majority (86%, 89/104) were observed having difficulties with at least one of these steps. Misinterpretation of HIV self-test results were common among FSWs: 23% (12/56) of FSWs interpreted HIV-negative self-test results as HIV positive and 8% (3/37) of FSWs interpreted HIV-positive self-test results as HIV negative. The concordance between FSWs' interpretations of self-test results and that indicated in the instructions was 73% (95% CI 56% to 86%) for HIV-positive self-tests and 68% (95% CI 54% to 80%) for HIV-negative self-tests. CONCLUSIONS: FSWs in Kampala, who performed unassisted HIV self-testing, skipped steps in the HIV self-testing process and had difficulties correctly interpreting self-test results. Training on use and interpretation of HIV self-tests may be necessary to prevent errors in the HIV self-testing process and to avoid the negative consequences of false-positive and false-negative HIV self-test results among FSWs. TRIAL REGISTRATION NUMBER: NCT02846402.