Browsing by Author "Okoboi, Stephen"
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Item Community‑based ART distribution system can effectively facilitate long‑term program retention and low‑rates of death and virologic failure in rural Uganda(AIDS research and therapy, 2015) Okoboi, Stephen; Ding, Erin; Persuad, Steven; Wangisi, Jonathan; Birungi, Josephine; Shurgold, Susan; Kato, Darius; Nyonyintono, Maureen; Egessa, Aggrey; Bakanda, Celestin; Munderi, Paula; Kaleebu, Pontiano; Moore, David M.Community-drug distribution point is a care model for stable patients in the community designed to make ART delivery more efficient for the health system and provide appropriate support to encourage long-term retention of patients. We examined program retention among ART program participants in rural Uganda, which has used a community-based distribution model of ART delivery since 2004. Methods: We analyzed data of all patients >18 years who initiated ART in Jinja, Ugandan site of The AIDS Support Organization between January 1, 2004 and July 31, 2009. Participants attended clinic or outreach visits every 2–3 months and had CD4 cell counts measured every 6 months. Retention to care was defined as any patient with at least one visit in the 6 months before June 1, 2013. We then identified participants with at least one visit in the 6 months before June 1, 2013 and examined associations with mortality and lost-to-follow-up (LTFU). Participants with >4 years of follow up during August, 2012 to May, 2013 had viral load conducted, since no routine viral load testing was available. Results: A total of 3345 participants began ART during 2004–2009. The median time on ART in June 2013 was 5.69 years. A total of 1335 (40 %) were residents of Jinja district and 2005 (60 %) resided in outlying districts. Of these, 2322 (69 %) were retained in care, 577 (17 %) died, 161 (5 %) transferred out and 285 (9 %) were LTFU. Factors associated with mortality or LTFU included male gender, [Adjusted Hazard Ratio (AHR) = 1.56; 95 % CI 1.28–1.9], CD4 cell count <50 cells/μL (AHR = 4.09; 95 % CI 3.13–5.36) or 50–199 cells/μL (AHR = 1.86; 95 % CI 1.46–2.37); ART initiation and WHO stages 3 (AHR = 1.35; 95 % CI 1.1–1.66) or 4 (AHR = 1.74; 95 % CI 1.23–2.45). Residence outside of Jinja district was not associated with mortality/LTFU (p value = 0.562). Of 870 participants who had VL tests, 756 (87 %) had VLs <50 copies/mL. Conclusion: Community-based ART distribution systems can effectively mitigate the barriers to program retention and result in good rates of virologic suppression.Item Durability Of Non-Nucleotide Reverse Transcriptase Inhibitor-Based First-Line ART Regimens After 7 Years Of Treatment In Rural Uganda(Medicine, 2021) Nanfuka, Mastula; Forrest, Jamie I.; Zhang, Wendy; Okoboi, Stephen; Birungi, Josephine; Kaleebu, Pontiano; Zhu, Julia; Tibenganas, Samuel; Moore, David M.Most antiretroviral therapy (ART) programs in resource-limited settings have historically used non-nucleotide reverse transcriptase inhibitor (NNRTI)-based regimens with limited access to routine viral load (VL) testing. We examined the long-term success of these regimens in rural Uganda among participants with 1 measured suppressed VL. We conducted a prospective cohort study of participants who had been on NNRTI-based first-line regimens for ≥4years and had a VL <1000copies/mL at enrollment in Jinja, Uganda. We collected clinical and behavioral data every 6 months and measured VL again after 3 years. We quantified factors associated with virologic failure (VF) (VL≥1000copies/mL) using Wilcoxon Rank Sum, chisquare, and Fisher’s Exact Tests. We enrolled 503 participants; 75.9% were female, the median age was 45years, and the median duration of time on ART was 6.8 years (IQR=6.0–7.6 years). Sixty-nine percent of participants were receiving nevirapine, lamivudine, and zidovudine regimens; 22.5% were receiving efavirenz, lamivudine, and zidovudine; and 8.6% were receiving other regimens. Of the 479 with complete follow-up data, 12 (2.5%) had VL≥1000copies/mL. VF was inversely associated with reporting never missing pills (41.7% of VFs vs 72.8% non-VFs, P=.034). There were differences in distribution of the previous ART regimens (P=.005), but no clear associations with specific regimens. There was no association between having a VL of 50 to 999copies/mL at enrollment and later VF (P=.160). Incidence of VF among individuals receiving ART for nearly 7 years was very low in the subsequent 3 years. NNRTI-based regimens appear to be very durable among those with good initial adherence.Item Effect of disclosure of HIV Status on Patient rRepresentation and Adherence to Clinic visits in Eastern Uganda: A Propensity-score Matched Analysis(Plos one,, 2021) Izudi, Jonathan; Okoboi, Stephen; Lwevola, Paul; Kadengye, Damazo; Bajunirwe, FrancisDisclosure of human immunodeficiency virus (HIV) status improves adherence to antiretroviral therapy (ART) and increases the chance of virological suppression and retention in care. However, information on the effect of disclosure of HIV status on adherence to clinic visits and patient representation is limited. We evaluated the effects of disclosure of HIV status on adherence to clinic visits and patient representation among people living with HIV in eastern Uganda.In this quasi-randomized study, we performed a propensity-score-matched analysis on observational data collected between October 2018 and September 2019 from a large ART clinic in eastern Uganda. We matched participants with disclosed HIV status to those with undisclosed HIV status based on similar propensity scores in a 1:1 ratio using the nearest neighbor caliper matching technique. The primary outcomes were patient representation (the tendency for patients to have other people pick-up their medications) and adherence to clinic visits. We fitted a logistic regression to estimate the effects of disclosure of HIV status, reported using the odds ratio (OR) and 95% confidence interval (CI).Of 957 participants, 500 were matched. In propensity-score matched analysis, disclosure of HIV status significantly impacts adherence to clinic visits (OR = 1.63; 95% CI, 1.13–2.36) and reduced patient representation (OR = O.49; 95% CI, 0.32–0.76). Sensitivity analysis showed robustness to unmeasured confounders (Gamma value = 2.2, p = 0.04).Disclosure of HIV status is associated with increased adherence to clinic visits and lower representation to collect medicines at the clinic. Disclosure of HIV status should be encouraged to enhance continuity of care among people living with HIV.Item Effect of the COVID-19 Pandemic Restrictions on Outcomes of HIV Care among Adults in Uganda(Medicine, 2022) Izudi, Jonathan; Kiragga, Agnes; Kalyesubula, Philip; Okoboi, Stephen; Castelnuovo, BarbaraUganda enforced several stringent restrictions such as night-time curfews, travel bans, school closure, and physical and social distancing among others that constituted a national lockdown to prevent the spread of the Coronavirus disease 2019 (COVID-19). These restrictions disrupted the delivery of health services but the impact on outcomes of human immunodeficiency virus (HIV) care has not been rigorously studied. We evaluated the effect of the COVID-19 pandemic restrictions on outcomes of HIV care among people living with HIV (PLHIV) aged ≥15 years in Kampala, Uganda. We designed a nonrandomized, quasi-experimental study using observational data retrieved from six large HIV clinics and used the data to construct two cohorts: a comparison cohort nonexposed to the restrictions and an exposed cohort that experienced the restrictions. The comparison cohort consisted of PLHIV commenced on anti-retroviral therapy (ART) between March 1, 2018, and February 28, 2019, followed for ≥1 year with outcomes assessed in March 2020, just before the restrictions were imposed. The exposed cohort comprised of PLHIV started on ART between March 1, 2019, and February 28, 2020, followed for ≥1 year with outcomes assessed in June 2021. The primary outcomes are retention, viral load testing, viral load suppression, and mortality. We employed inverse probability of treatment weighting using propensity score (IPTW-PS) to achieve comparability between the two cohorts on selected covariates. We estimated the effect of the restriction on the outcomes using logistic regression analysis weighted by propensity scores (PS), reported as odds ratio (OR) and 95% confidence interval (CI). We analyzed data for nine, 952 participants, with 5094 (51.2%) in the exposed group. The overall mean age was 32.7 ± 8.8 years. In the exposed group relative to the comparison group, viral load testing (OR, 1.68; 95% CI, 1.59–1.78) and viral load suppression (OR, 1.34; 95% CI, 1.110–1.63) increased while retention (OR, 0.76; 95% CI, 0.70–0.81) and mortality (OR, 0.75; 95% CI, 0.64–0.88) reduced. Among PLHIV in Kampala, Uganda, viral load testing and suppression improved while retention and mortality reduced during the COVID-19 pandemic restrictions due to new approaches to ART delivery and the scale-up of existing ART delivery models.Item Factors associated with long-term antiretroviral therapy attrition among adolescents in rural Uganda: a retrospective study(Journal of the International AIDS Society, 2016) Okoboi, Stephen; Ssali, Livingstone; Yansaneh, Aisha I.; Bakanda, Celestin; Birungi, Josephine; Nantume, Sophie; Lyavala Okullu, Joanne; Sharp, Alana R.; Moore, David M.; Kalibala, SamuelAs access to antiretroviral therapy (ART) increases, the success of treatment programmes depends on ensuring high patient retention in HIV care. We examined retention and attrition among adolescents in ART programmes across clinics operated by The AIDS Support Organization (TASO) in Uganda, which has operated both facility- and community-based distribution models of ART delivery since 2004. Methods: Using a retrospective cohort analysis of patient-level clinical data, we examined attrition and retention in HIV care and factors associated with attrition among HIV-positive adolescents aged 10 19 years who initiated ART at 10 TASO clinics between January 2006 and December 2011. Retention in care was defined as the proportion of adolescents who had had at least one facility visit within the six months prior to 1 June 2013, and attrition was defined as the proportion of adolescents who died, were lost to follow-up, or stopped treatment. Descriptive statistics and Cox proportional hazards regression models were used to determine the levels of retention in HIV care and the factors associated with attrition following ART initiation. Results: A total of 1228 adolescents began ART between 2006 and 2011, of whom 57% were female. The median duration in HIV care was four years (IQR 3 6 years). A total of 792 (65%) adolescents were retained in care over the five-year period; 36 (3%) had died or transferred out and 400 (32%) were classified as loss to follow-up. Factors associated with attrition included being older (adjusted hazard ratio (AHR) 1.38, 95% confidence interval (CI) 1.02 1.86), having a higher CD4 count (250 cells/mm3) at treatment initiation (AHR 0.49, 95% CI 0.34 0.69) and HIV care site with a higher risk of attrition among adolescents in Gulu (AHR 2.26; 95% CI 1.27 4.02) and Masindi (AHR 3.30, 95% CI 1.87 5.84) and a lower risk of attrition in Jinja (AHR 0.24, 95% CI 0.08 0.70). Having an advanced WHO clinical stage at initiation was not associated with attrition. Conclusions: We found an overall retention rate of 65%, which is comparable to rates achieved by TASO’s adult patients and adolescents in other studies in Africa. Variations in the risk of attrition by TASO treatment site and by clinical and demographic characteristics suggest the need for early diagnosis of HIV infection, use of innovative approaches to reach and retain adolescents living with HIV in treatment and identifying specific groups, such as older adolescents, that are at high risk of dropping out of treatment for targeted care and support.Item Factors Associated with Uptake of Contraceptives among HIV Positive Women on Dolutegravir based Anti-Retroviral Treatment at Health Centres of Kampala Capital City Authority. A cross sectional study in Uganda.(BMC Women's Health, 2022) Mbabazi, Leah; Nabaggala, Mariah Sarah; Kiwanuka, Suzanne; Kiguli, Juliet; Okoboi, Stephen; Laker, Eva; Castelnuovo, Barbara; Lamorde, Mohammed; Kiconco, Arthur; Amperiize, MathiusIn May 2018, the World Health Organisation issued a teratogenicity alert for HIV positive women using dolutegravir (DTG) and emphasised increased integration of sexual and reproductive services into HIV care to meet contraceptive needs of HIV positive women. However, there are scarce data on the impact of this guidance on contraceptive uptake. Objective To investigate the uptake of contraceptives and the factors affecting the uptake of contraceptive services among the HIV positive women of reproductive age who use DTG. Methods A cross-sectional survey was conducted from April 2019 to July 2019, in five government clinics in central Uganda where DTG was offered as the preferred first-line antiretroviral treatment (ART) regimen. We randomly selected 359 non-pregnant women aged 15-49 years using DTG-based regimens. We used interviewer administered questionnaires to collect data on demographics, contraceptive use, social and health system factors. We defined contraceptive uptake as the proportion of women using any method of contraception divided by the total number of women on DTG during the review period. We described patients’ characteristics using descriptive statistics. Factors associated with contraceptive uptake were investigated using Poisson regression at multivariable analysis (STATA 14). Results Of the 359 participants, the mean age was 37(SD=6.8), half 50.7% had attained primary level of education and average monthly income <100,000Ushs. The overall level of Contraceptive uptake was 38.4%, modern contraceptive uptake was 37.6% and 96.4% of the participants had knowledge of contraceptives. The most utilised method was the injectable at 58.4% followed by condoms 15%, IUD 10.7%, pills 6.4%, implants 5.4%, and least used was sterilization at 0.7%. Predictor factors that increased likelihood of contraceptive uptake were; religion of others category AIRR=1.53(95% CI: 1.01, 2.29) and parity 3-4 children AIRR=1.48(95% CI: 1.14, 1.92). Reduced rates were observed for age 40-49 years AIRR=0.45(95% CI: 0.21, 0.94), unemployment AIRR 0.63(95% CI: 0.42, 0.94), not discussing FP with partner AIRR=0.39(95% CI: 0.29, 0.52) and not receiving FP counselling AIRR=2.86 (95% CI: 0.12, 0.73). Non-significant variables were facility, education level, marital status, sexual activity, experienced side effects of FP and knowledge on both contraceptives and DTG. Conclusion This study shows a low-level uptake of contraceptives and injectable was the most used method. It also indicated that FP counselling and partner discussion on FP increased contraceptive uptake. Therefore, more strategies should be put in place to increase male involvement in family planning programs and scale up the integration of family planning services into HIV care and management programs.Item No differences in clinical outcomes with the addition of viral load testing to CD4 cell count monitoring among HIV infected participants receiving ART in rural Uganda: Long-term results from the Home Based AIDS Care Project(BMC Public Health, 2015) Okoboi, Stephen; Ekwaru, Paul John; Campbell, James D.; Egessa, Aggrey; King, Racheal; Bakanda, Celestin; Muramuzi, Emmy; Kaharuza, Frank; Malamba, Samuel; Moore, David M.We compared clinical outcomes among HIV-infected participants receiving ART who were randomized to viral load (VL) and CD4 cell count monitoring in comparison to CD4 cell count monitoring alone in Tororo, Uganda. Methods: Beginning in May 2003, participants with CD4 cell counts <250 cells/μL or WHO stage 3 or 4 disease were randomized to clinical monitoring alone, clinical monitoring plus quarterly CD4 cell counts (CD4-only); or clinical monitoring, quarterly CD4 cell counts and quarterly VL testing (CD4-VL). In 2007, individuals in clinical monitoring arm were re-randomized to the other two arms and all participants were followed until March 31, 2009. We used Cox Proportional Hazard models to determine if study arm was independently associated with the development of opportunistic infections (OIs) or death. Results: We randomized 1211 participants to the three original study arms and 331 surviving participants in the clinical monitoring arm were re-randomized to the CD4-VL and CD4 only arms. At enrolment the median age was 38 years and the median CD4 cell count was 134 cells/μL. Over a median of 5.2 years of follow-up, 37 deaths and 35 new OIs occurred in the VL-CD4 arm patients, 39 deaths and 42 new OIs occurred in CD4-only patients. We did not observe an association between monitoring arm and new OIs or death (AHR =1.19 for CD4-only vs. CD4-VL; 95 % CI 0.82–1.73). Conclusion: We found no differences in clinical outcomes associated with the addition of quarterly VL monitoring to quarterly CD4 cell count monitoring.Item A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda(BMC, 2020) MacCarthy, Sarah; Wagner, Zachary; Mendoza-Graf, Alexandra; Gutierrez, Carlos Ignacio; Samba, Clare; Birungi, Josephine; Okoboi, Stephen; Linnemayr, SebastianBackground: Studies report serious adherence problems among youth (individuals age 15–24 years of age) in Uganda. Recent growth in mobile phone ownership has highlighted the potential of using text-based interventions to improve antiretroviral treatment (ART) adherence among Ugandan youth. We piloted a randomized controlled trial of a text-based intervention providing weekly real-time antiretroviral adherence feedback, based on information from a smart pill box, to HIV-positive Ugandan youth. In this paper, we report the acceptability, feasibility, and preliminary impact of the intervention. Methods: We randomized participants to a control group, or to receive messages with information on either their own adherence levels (Treatment 1 - T1), or their own adherence and peer adherence levels (Treatment 2 – T2). We conducted six focus groups from December 2016 to March 2017 with providers and youth ages 15–24, double coded 130 excerpts, and achieved a pooled Cohen’s Kappa of 0.79 and 0.80 based on 34 randomly selected excerpts. Results: The quantitative and qualitative data show that the intervention was deemed acceptable and feasible. After controlling for baseline adherence, the T1 group had 3.8 percentage point lower adherence than the control group (95% CI -9.9, 2.3) and the T2 group had 2.4 percentage points higher adherence than the control group (95% CI -3.0, 7.9). However, there was an increasing treatment effect over time for the T2 group with the largest effect towards the end of the study; a 2.5 percentage point increase in the initial 9-weeks that grows steadily to 9.0 percentage points by the last 9-weeks of the study. We find negative treatment effects for T1 in 3 of the 4 9-week intervals. This pilot study was not designed to detect statistically significant differences. Conclusions: Improving youth’s adherence by supplementing information about their adherence with information about the adherence of peers is a promising new strategy that should be further evaluated in a fully-powered study. Providing one’s own adherence information alone appears to have less potential.Item Researchers experience of using the regulatory affairs information system (RAIS) in strengthening research compliance in a large research program; A case study of the Infectious Diseases Institute(IDI) in Uganda(JAMIA open, 2022) Nabukenya, Sylvia; Okoboi, Stephen; Nakate, Vivian; Twimukye, Adelline; Opio, Bruce; Castelnuovo, BarbaraThe aim of this study was to explore researchers’ experience of using the regulatory affairs information system (RAIS) in strengthening research compliance to national ethics guidelines through tracking ethics and regulatory approvals for research projects at the Infectious Diseases Institute. We conducted a cross-sectional study using purposive sampling of 50 participants who were principal investigators (PI) and study coordinators (SC) of active projects between November 2019 and January 2020. Only 36 of them responded to the survey. We also conducted 12 key informant interviews among PI, SC, and research management at the Institute. We used STATA 13 to analyze responses to the survey. The interviews lasted between 20 and 30 min. We used NVivo 10 software to manage the transcripts and generation of themes. Majority 19 (52.8%) of those who participated in the survey were study coordinators, 19 (52.8%) had participated in more than 5 research studies, 28 (90.3%) had ever received a notification from the RAIS and 26 (92.9%) submitted requests for renewal of their studies approvals to Ethics committees and regulatory bodies 4 weeks prior to expiration dates. The study also examined participants’ general understanding of the regulatory requirements and all were aware that RECs and NDA grant approval for a period of 1 year, and 35 (97.2%) that UNCST grants approval for the duration of the study. Three prominent themes; researchers’ experiences, benefits, and shortcomings of RAIS were generated from the key informant interviews. Having experience in research coupled with a novel automated system provides a platform for a better understanding of research regulatory requirements, hence compliance to the national guidelines. Our case study demonstrates that supporting researchers and research institutions in low resource settings with an automated system in tracking expiration dates for research approvals can facilitate compliance to national ethics guidelines.Item A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda(BMC medical ethics, 2021) Ainembabazi, Provia; Castelnuovo, Barbara; Okoboi, Stephen; Arinaitwe, Walter Joseph; Parkes‑Ratanshi, Rosalind; Byakika‑Kibwika, PaulineOver the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review. Methods: This was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies. Results: We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29). Conclusion: Competence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.