Browsing by Author "Lalloo, David G."

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    Barriers to starting ART and how they can be overcome: individual and operational factors associated with early and late start of treatment
    (Tropical medicine & international health, 2010) Parkes-Ratanshi, Rosalind; Bufumbo, Leonard; Nyanzi-Wakholi, Barbara; Levin, Jonathan; Grosskurth, Heiner; Lalloo, David G.; Kamali, Anatoli
    Despite expanding access to antiretroviral therapy (ART) in Sub-Saharan Africa, there are few data on patients’ perceptions about starting ART to explore issues affecting decisions to start ART in eligible individuals during the ART roll out. Methods We studied patterns of ART uptake for 957 participants in a trial of cryptococcal disease prevention and performed a qualitative cross-sectional study about issues affecting decisions to start ART in this cohort. In-depth interviews (IDIs) were conducted with 48 participants who started ART after variable time on the trial. results Time to starting ART from trial enrolment decreased during the ART roll out (Median 83 days to 68 days). Multiple factors causing delay to ART were reported; awaiting home visit by service provider (P = 0.025), domestic issues (P = 0.028), moving from area (P £ 0.001) and fear of side effects (P = 0.013) were statistically significant. In the IDIs, fear of side effects was the strongest factor for delay and observation of health improvement in others on ART was the strongest inducement to start. Information from patients already taking ART was the most valued source of information. Conclusions This study provided novel information about factors encouraging people to start ART early; positive beliefs about ART were the most important. Whilst side effects of ART must not be downplayed, programmes should provide information in a balanced way to prevent unnecessary fear of starting ART. Those already receiving ART were found to be good advocates and should be utilised by ART programmes to educate others.
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    Pregnancy in HIV Clinical Trials in Sub Saharan Africa: Failure of Consent or Contraception?
    (PLoS ONE, 2013) Ssali, Agnes; Namukwaya, Stella; Bufumbo, Leonard; Seeley, Janet; Lalloo, David G.; Parkes-Ratanshi, Rosalind; Kamali, Anatoli
    Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa. Methods: Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP); and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO). 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use. Results: All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel) would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.