Kabwohe Clinical Research Center

Kabwohe, Uganda

Kabwohe Clinical Research Center

Kabwohe, Uganda

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Haberer J.E.,Massachusetts General Hospital | Haberer J.E.,Harvard University | Baeten J.M.,University of Washington | Campbell J.,Centers for Disease Control and Prevention | And 18 more authors.
PLoS Medicine | Year: 2013

Background:Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Methods and Findings:Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to <80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants-all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, p<0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%-100%) by unannounced pill counts and 97.2% (90.6%-100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with <80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.Conclusions:The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use.Please see later in the article for the Editors' Summary. © 2013 Haberer et al.


Baeten J.M.,University of Washington | Donnell D.,University of Washington | Donnell D.,Fred Hutchinson Cancer Research Center | Ndase P.,University of Washington | And 49 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. METHODS: We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens - once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo - and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. RESULTS: We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P = 0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study. CONCLUSIONS: Oral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.) Copyright © 2012 Massachusetts Medical Society.


Ndase P.,University of Washington | Celum C.,University of Washington | Campbell J.,Centers for Disease Control and Prevention | Bukusi E.,University of Washington | And 14 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2014

Background: Dissemination of research results to study participants and stakeholders and provision of proven effective products in the immediate post-trial period are core elements of the conduct of biomedical HIV prevention clinical trials. Few biomedical HIV prevention trials have demonstrated HIV protection with novel interventions, and thus, communication of positive trial results and provision of an effective product have not been tested in many situations. Methods: In July 2011, the independent Data and Safety Monitoring Board of the Partners PrEP Study, a randomized, placebo-controlled efficacy trial of daily oral antiretroviral preexposure prophylaxis (PrEP) for HIV prevention among 4747 African heterosexual HIV serodiscordant couples, recommended discontinuation of the trial's placebo arm due to demonstration of PrEP efficacy. We describe dissemination of results, discontinuation of the placebo arm, and provision of active PrEP to participants' formerly assigned placebo. Results: Within 72 hours, of the Data and Safety Monitoring Board meeting the study results were publicly released and disseminated to stakeholders and study participants. Within 3 months, the study protocol was modified to permit participants initially assigned to the study's placebo arm to be offered active PrEP. Of the 1418 participants initially randomized to placebo who were clinically eligible to receive PrEP, 89.1% (1264/1418) consented. Conclusions: Prompt dissemination of a positive HIV prevention trial result and subsequent provision of effective product to research participants was feasible and efficient for >4700 HIV serodiscordant couples in East Africa. The extent to which study sponsors can assure continued product access to research participants remains a subject of discussion for future HIV prevention clinical trials. Copyright © 2014 by Lippincott Williams & Wilkins.


PubMed | Centers for Disease Control and Prevention, University of Washington, Kenya Medical Research Institute, The AIDS Support Organization and 3 more.
Type: Journal Article | Journal: PloS one | Year: 2015

During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.


PubMed | Kenya Medical Research Institute, University of Washington, Jomo Kenyatta University of Agriculture and Technology, Makerere University and Kabwohe Clinical Research Center
Type: Journal Article | Journal: BMC infectious diseases | Year: 2016

Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) reduce HIV-1 transmission within heterosexual HIV-1 serodiscordant couples. Prioritizing couples at highest HIV-1 transmission risk for ART and PrEP would maximize impact and minimize costs.The Partners Demonstration Project is an open-label, delivery study of integrated PrEP and ART for HIV-1 prevention among high risk HIV-1 serodiscordant couples in Kenya and Uganda. We evaluated the feasibility of using a validated risk score that weighs a combination of easily measurable factors (age, children, marital status, male circumcision status, condom use, plasma HIV-1 levels) to identify couples at highest risk for HIV-1 transmission for enrollment. Couples scoring 5 met the risk score eligibility criteria.We screened 1694 HIV-1 serodiscordant couples and enrolled 1013. Of the screened couples, 1331 (78.6%) scored 5 (with an expected incidence >3% per year) and 76% of these entered the study. The median age of the HIV-1 uninfected partner was 29years [IQR 26, 36] and 20% were <25years of age. The HIV-1 uninfected partner was male in 67% of partnerships, 33% of whom were uncircumcised, 57% of couples had no children, and 65% reported unprotected sex in the month prior to enrollment. Among HIV-1 infected partners, 41% had plasma viral load >50,000 copies/ml.A risk scoring tool identified HIV-1 serodiscordant couples for a demonstration project of PrEP and ART with high HIV-1 risk. The tool may be feasible for research and public health settings to maximize efficiency and minimize HIV-1 prevention costs.


Kamara N.T.,Sudan University of Science and Technology | Asiimwe S.,Kabwohe Clinical Research Center
Tropical Doctor | Year: 2010

Dyslipidaemia and hypertension in patients with diabetes increase the riskofmacrovascularandmicrovascular complications.We tookanthropometricmeasurements, lipids, bloodpressure and fastingblood sugarof 150 diabetics and151non-diabetics.Among the diabetics, 17 (11.3%) had total cholesterol (TC) ≥200 mg/dL,70 (46.6%) hadtriglycerides (TG)≥150 mg/dL,78(52%)hadhighdensity lipoprotein (HDL)≤40 mg/dL and 26 (17.3%) hadlowdensity lipoprotein (LDL) ≥100 mg/dL.Diabeticsweremore likely to have raisedTG,OR = 1.88 (95%CI1.17 - 3.00), P= 0.01; high systolic blood pressure (SBP),OR= 3.22 (95%CI 1.86 - 5.59), P= 0.01; and highdiastolic blood pressure (DBP)OR = 4.11(95%CI 1.86 - 5.59), P= 0.01.The prevalence ofHDL and TG dyslipidaemiaamong the diabetics inUganda is significantly higher thaninnon-diabetics, as is the prevalence of systolic and diastolic hypertension. Other studies need to be done to assess the effect of lipids on cardiovascular disease, mortality and morbidity in diabetic patients in Uganda.


Mujugira A.,University of Washington | Celum C.,University of Washington | Thomas K.K.,University of Washington | Farquhar C.,University of Washington | And 7 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2014

Objective:: WHO guidance recommends antiretroviral therapy (ART) initiation for all persons with a known HIV-uninfected partner, as a strategy to prevent HIV transmission. Uptake of ART among HIV-infected partners in serodiscordant partnerships is not known, which we evaluated in African HIV serodiscordant couples. Design:: Prospective cohort study. Methods:: Among HIV-infected persons from Kenya and Uganda who had a known heterosexual HIV-uninfected partner, we assessed ART initiation in those who became ART eligible under national guidelines during follow-up. Participants received quarterly clinical and semi-annual CD4 monitoring, and active referral for ART upon becoming eligible. Results:: Of 1958 HIV-infected ART-eligible partners, 58% were women, and the median age was 34 years. At the first visit when determined to be ART eligible, the median CD4 count was 273 cells per microliter (interquartile range, 221-330), 77% had WHO stage 1 or 2 HIV disease, and 96% were receiving trimethoprim-sulfamethoxazole prophylaxis. The cumulative probabilities of initiating ART at 6, 12, and 24 months after eligibility were 49.9%, 70.0%, and 87.6%, respectively. Younger age [<25 years; adjusted hazard ratio (AHR), 1.39; P = 0.001], higher CD4 count (AHR, 1.95; P < 0.001 for >350 compared with <200 cells/μL), higher education (AHR, 1.25; P < 0.001), and lack of income (AHR, 1.15; P = 0.02) were independent predictors for delay in ART initiation. Conclusions:: In the context of close CD4 monitoring, ART counseling, and active linkage to HIV care, a substantial proportion of HIV-infected persons with a known HIV-uninfected partner delayed ART initiation. Strategies to motivate ART initiation are needed, particularly for younger persons with higher CD4 counts. Copyright © 2014 by Lippincott Williams & Wilkins.


PubMed | Kabwohe Clinical Research Center, Makerere University and UVRI IAVI HIV Vaccine Program
Type: Journal Article | Journal: PloS one | Year: 2015

Fishing communities (FCs) in Uganda have high HIV infection rates but poor access to health services including family planning (FP). Although FP is a cost-effective public health intervention, there is a paucity of data on knowledge and use of modern FP in FCs. This study determined knowledge and use of modern FP methods in FCs of Uganda.Data were accrued from a 12-month follow up of 1,688 HIV-uninfected individuals, 18-49 years from 8 FCs along Lake Victoria, between September 2011 and March 2013. Data on knowledge and use of modern FP were collected through a semi-structured questionnaire. Prevalence Risk Ratios with corresponding 95% CIs were used to determine factors associated with Modern FP knowledge and use.The mean age was 31.4 years, with nearly half (48.8%) being females while more than half (58.6%) had attained up to primary education level. Knowledge of modern FP was high, 87.5% (1477/1688); significantly higher among females [adj. PRR = 4.84 (95% CI; 3.08, 7.61)], among older respondents (25-29 years) [adj. PRR = 1.83 (95% CI; 1.12, 2.99)] compared to younger ones (18-24 years) and among those conducting business [adj. PRR = 2.42(95% CI; 1.02, 5.74)] relative to those primarily in fishing. Just over a third (35.2%, 595/1688) reported use of at least one modern FP method. Use of modern FP methods was significantly higher among females [adj. PRR = 2.04 (95% CI; 1.56, 2.65, and among those reporting multiple sexual partnerships [adj. PRR = 2.12, 95% CI; 1.63, 2.76)]. Nonuse of modern methods was mostly due to desire for more children (30.6%), fear of side effects (12.2%) and partner refusal (5.2%).Despite their high knowledge of FP, FCs have low use of modern FP methods. Key barriers to use of modern FP methods were high fertility desires, fear of perceived side effects and partner refusal of methods.


Ware N.C.,Harvard University | Wyatt M.A.,Harvard University | Haberer J.E.,Massachusetts General Hospital | Baeten J.M.,University of Washington | And 7 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2012

Objective: Adherence may be the "Achilles heel" of pre-exposure prophylaxis (PrEP), a promising biomedical approach to HIV prevention. This article presents an explanation of PrEP adherence for African serodiscordant couples derived from qualitative data. Design: Explaining quantitative findings is one way qualitative investigation contributes to research in medicine and public health. This qualitative interview study was nested in the Partners PrEP Study, a phase III randomized trial evaluating oral tenofovir and emtricitabine/tenofovir PrEP to prevent HIV acquisition by HIVuninfected partners in serodiscordant heterosexual couples. Methods: In-depth qualitative interviews were provided by 60 Partners PrEP Study participants in Uganda. Interviews used openended questions eliciting information on adherence experiences, barriers, and facilitators. An inductive approach informed by grounded theory methodology was used to analyze study data. Results: The proposed explanation may be summarized as follows. Serodiscordance destabilizes couples, as the HIV-negative partner reacts with anger, fear, and sadness to the implication of infidelity represented by HIV infection. A "discordance dilemma" ensues, as the desire to avoid acquiring HIV and the advantages of preserving the relationship become competing priorities. PrEP is seen as a solution-a means of safeguarding health without ending the relationship. PrEP users benefit from the support of partners, who reinforce adherence. Where discord in the relationship persists, adherence suffers. Conclusions: PrEP adherence in serodiscordant couples may be understood as a function of the desire to reduce risk although preserving a partnered relationship. PrEP use in stable couples may be associated with improved adherence and thus, greater effectiveness. © 2012 Lippincott Williams &Wilkins.

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