Browsing by Author "Kamali, Anatoli"

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Participation in Clinical Research Could Modify Background Risk for Trial Outcome Measures
(2014) Ndibazza, Juliet; Abaasa, Andrew M.; Asiki, Gershim; Levin, Jonathan; Bahemuka, Ubaldo; Ruzagira, Eugene; Kibengo, Freddie M.; Mulondo, Jerry; Price, Matthew A.; Fast, Pat; Kamali, Anatoli
Data on HIV incidence and retention are needed to inform study design of efficacy trials. However, the selection criteria and interventions during an actual clinical trial could reduce HIV incidence and thus affect the statistical power. Weinvestigated the effect of inclusion and participation in a simulated vaccine efficacy trial (SiVET) on HIV and pregnancy incidence in a fisherfolk cohort in SW Uganda. High-risk vounteers aged 18–49 years from fishing communities 30-40 km from the MRC/UVRI research centre were recruited in HIV open cohort. High risk was defined as history of multiple sex partners, unprotected sex, STI presence and absence from home for ‡ 2 days in the preceding 3 months. Consenting volunteers with at least 3 months of follow-up, no contraindications for hepatitis B vaccine and willing to use contraception were administered a licensed Hepatitis B vaccine at 0, 1 and 6 months to mimic a candidate vaccine. The cohort was followed quarterly for a year. HIV incidence, pregnancy and retention rates were compared. Results: Of 853 (55% men) individuals screened from Jan 2012-Feb 2014, 575 (60% men, mean age 28) were enrolled into the open cohort, 282 (73% men) of whom enrolled into the SiVET between July, 2012-Feb 2013. In both groups there was reduction of risky behaviours, (p < 0.05). A total of 13 HIV incident cases occurred in 93.0 PYO [brackets 95% CI]; incidence 13.9/100 PYO [8.1-24.1] and 10 cases in 311.6 PYO; incidence 3.2 [1.7-6.0] in the open cohort and SiVET respectively. A total of 26 pregnancies were observed in 42.7 Women Years of Observation(WYO); incidence 60.9 [41.5-89.5], and 4 pregnancies (71.4WYO); incidence 5.6 [2.1-14.8] in the open cohort and SiVET respectively.
A Randomised Placebo-Controlled Safety and Acceptability Trial of PRO 2000 Vaginal Microbicide Gel in Sexually Active Women in Uganda
(BMJ Publishing Group, 2010) Kamali, Anatoli; Byomire, Helen; Muwonge, Catherine; Bakobaki, Julie; Rutterford, Clare; Okong, Pius; Profy, Albert; Byaruhanga, Romano; Namukwaya, Stella; McCormack, Sheena; Grosskurth, Heiner; Nunn, J Andrew; Lacey, J.N. Charles
Abstract Objectives To determine the safety of 0.5% and 2% PRO 2000 gel in terms of local and systemic adverse events (AE) and the acceptability of gel use. Design A randomised placebo-controlled trial among healthy, sexually active African women aged 18–45 years. Between June 2003 and September 2004, 180 consenting women were randomly assigned to one of four groups: PRO 2000 gel (0.5% or 2%), placebo gel, or condom use only. Participants were screened for sexually transmitted infections, with HIV counselling and testing. Women randomly assigned to gel used this intravaginally twice a day for 28 days. Follow-up visits were fortnightly up to 6 weeks from enrolment, and comprised a physical examination including colposcopy, laboratory testing and questionnaire interviews. Results Ten women were lost to follow-up, none due to AE. Adherence with total gel doses was 69%. Observed rates of the primary toxicity endpoints, ulceration greater than 2×1 cm and clinically relevant coagulation abnormalities were, for PRO 2000 0.5%: 1.6% (95% CI 0.04% to 8.5%) and 0% (97.5% CI 0% to 5.7%), and for PRO 2000 2%: 0% and 0% (97.5% CI 0% to 5.9%). Women randomly assigned to active gels did not show an increased rate of AE. Gel use had no significant effect on haematology and biochemistry results. Women found gel use highly acceptable. Conclusions Both concentrations of PRO 2000 gel were found to be safe and well tolerated. These data justified testing the gels in large-scale effectiveness trials.
Trends of Reported HIV Sexual Risk Behaviour and HIV Incidence Among Fisher Folk in Uganda Receiving Clinic-Based Routine HIV Counseling and Testing
(2009) Ndibazza, Juliet; Asiki, Gershim; Mulondo, Jerry; Price, Matthew Andrew; Fast, Patricia; Kamali, Anatoli; Bahemuka, Ubaldo Mushabe; Abaasa, Andrew; Ruzagira, Eugene; Kibengo, Freddie Mukasa
HIV counseling and testing (HCT) has been shown to reduce HIV risk behaviorandis central to HIV prevention programs. We investigated risk behaviorand HIV incidenceTrendsin a fisher folkcohort on Lake Victoria, Uganda. HIV negative volunteers aged 18–49 years, at high risk of HIV infection and willing to undergo HCT were enrolled. Atevery quarterly visit, they received HCT. Condoms and STI treatment were also provided.Risk behaviordata on alcohol consumption before sex, multiple or new sex partners, condom use and exchange of gifts for sex in the past 3 months were collected at baseline and every 6 months for 2 years. We fitted multilevel logistic regression models to investigate the trends.A total of 428 (63% men) volunteers, mean age 28 years were enrolled. There were significant reductions in reported risk behaviorsover the 2-year follow-up. The proportion reporting ‡ 2 partners decreasedfrom 80% at baseline to 45% at month 6 and to 43% at month 24 for males; for females the decrease was from 42% at baseline to 13% at month 6 and to 6% at month 24; P < 0.01). Similarly there were significant reductions among men (P = 0.01) reportingnew partners but of borderline statistical significance among females (P = 0.09). In both sexes there were significant decreases in reported non-condom use, transactional sex and in having sex when drunk. HIV incidence (in brackets 95% CI) reduced from 8.2/100 person years (5.1-13.5), to 7.3 (5.0-10.6), 6.5 (4.6-9.1) and 6.0 (4.3-8.3) at 6, 12, 18 and 24 months respectively (p = 0.21). In this study therewas a substantial reduction in self-reported risk behaviour in the first 6 months and marginal reduction in the later period. However, a modest HIV incidence reduction was observed. This calls foran urgent need for combination prevention strategies in this population.Key Words: Sexual Risk Behaviour, HIVIncidence, FisherFolk, Clinic-based Routine, HIV Counseling and Testing