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Anna Dow,
Dumbani Kayira,
Michael Hudgens,
Annelies Van Rie,
Caroline C King,
Sascha Ellington, Athena Kourtis,
Abigail Norris Turner,
Steven Meshnick,
Zebrone Kacheche,
Denise J Jamieson,
Charles Chasela,
Charles van der Horst
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ABSTRACT: The World Health Organization guidelines recommend cotrimoxazole prophylactic treatment (CPT) for all HIV-exposed infants from age 6 weeks to the cessation of breastfeeding and the exclusion of HIV infection. There are limited data on the effects of CPT among this population of infants. We examined the effects of CPT on adverse health outcomes among HIV-exposed infants during the first 36 weeks of life using data from the Breastfeeding, Antiretrovirals and Nutrition study, a large clinical trial of antiretroviral drugs given to the mother or infant for the prevention of HIV transmission during breastfeeding.
For the analysis, we assigned a status of CPT-exposed to infants who were participating in the study after the CPT program started. We estimated unadjusted and adjusted hazard ratios for the effect of CPT status on time to incident malaria, severe illness or death, anemia, and weight-for-age Z score < -2.0. Participation in the study was limited to focus exclusively on HIV-exposed, uninfected infants.
The hazard ratio for the effect of CPT on incident malaria was 0.35 (95% confidence interval: 0.21, 0.57) during the first 10 weeks of CPT exposure and 0.93 (95% confidence interval: 0.67, 1.29) for the remaining 20 weeks. CPT was not associated with the other outcomes examined.
CPT offered temporary protection against malaria among HIV-exposed, uninfected infants. However, CPT offered no protection against anemia, low weight for age or the collapsed outcome of severe illness or death.
The Pediatric Infectious Disease Journal 08/2012; 31(8):842-7. · 3.58 Impact Factor
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Anna Dow,
Dumbani Kayira,
Michael Hudgens,
Annelies Van Rie,
Caroline C King,
Sascha Ellington, Athena Kourtis,
Abigail Norris Turner,
Steven Meshnick,
Zebrone Kacheche,
Denise J Jamieson,
Charles Chasela,
Charles van der Horst
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND:: The World Health Organization guidelines recommend cotrimoxazole prophylactic treatment (CPT) for all HIV-exposed infants from age 6 weeks to the cessation of breastfeeding and the exclusion of HIV infection. There are limited data about the effects of CPT among this population of infants. We examined the effects of CPT on adverse health outcomes among HIV-exposed infants during the first 36 weeks of life by using data from the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study, a large clinical trial of antiretroviral drugs given to the mother or infant for prevention of HIV transmission during breastfeeding. METHODS:: For the analysis, we assigned a status of CPT-exposed to infants who were participating in the study after the CPT program started. We estimated unadjusted and adjusted hazard ratios (HRs) for the effect of CPT status on time to incident malaria, severe illness or death, anemia, and weight-for-age Z score < -2.0. Participation in the study was limited to focus exclusively on HIV-exposed, uninfected infants. RESULTS:: The HR for the effect of CPT on incident malaria was 0.35 (95% confidence interval [CI]: 0.21, 0.57) during the first 10 weeks of CPT exposure, and 0.93 (95% CI: 0.67, 1.29) for the remaining 20 weeks. CPT was not associated with the other outcomes examined. CONCLUSIONS:: CPT offered temporary protection against malaria among HIV-exposed, uninfected infants. However, CPT offered no protection against anemia, low weight for age, or the collapsed outcome of severe illness or death.
The Pediatric Infectious Disease Journal 05/2012; · 3.58 Impact Factor
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ABSTRACT: The prevalence of diabetes in the United States is rising. As HIV-infected people live longer, they become more susceptible to chronic diseases such as diabetes. Additionally, some antiretroviral agents have been linked to impaired glucose tolerance and increased diabetes risk. To estimate the burden and trends of diabetes among hospitalized HIV-infected persons in the United States, we used data from the 1994-2004 Nationwide Inpatient Sample, a nationally representative survey of inpatient hospitalizations. Odds ratios (OR) and 95% confidence intervals (CI) were adjusted for demographic and hospital characteristics using logistic regression. Between 1994 and 2004, the rate of hospitalizations with a diabetes code per 100 hospitalizations increased from 3.9 to 8.4 (2.2 fold) among HIV-infected persons. Among HIV-uninfected people, the corresponding rate increased from 12.8 to 17.7 (1.4 fold). Since 1998, the mean age of HIV-infected hospitalized people with a diabetes diagnosis rose from 45 to 66 years and became similar to that of HIV-uninfected people. Compared to 1994-1996, in 2002-2004 the probability of hospitalizations with diabetes increased among both HIV-infected and HIV-uninfected persons (OR, 1.92, 95% CI, 1.79-2.05 and OR, 1.38, 95% CI, 1.36-1.40, respectively). Given the increasing prevalence of diabetes in hospitalized HIV-infected persons, it will be important to monitor the trends closely in addition to the effects of different types of antiretroviral regimens, in order to optimize comprehensive long-term care of HIV-infected persons.
Current HIV research 09/2009; 7(5):481-6. · 1.98 Impact Factor
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Yvonne Owens Ferguson,
Eugenia Eng,
Margaret Bentley,
Margarete Sandelowski,
Allan Steckler,
Elizabeth Randall-David,
Ellen G Piwoz,
Cynthia Zulu,
Charles Chasela,
Alice Soko, [......],
Gerald Tegha,
Roshan Thomas,
Hsiao-Chuan Tien,
Beth Tohill,
Esther Waalberg,
Jeffrey Wiener,
Cathy Wilfert,
Patricia Wiyo,
Onnocent Zgambo,
Chifundo Zimba
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ABSTRACT: A process evaluation of nurses' implementation of an infant-feeding counseling protocol was conducted for the Breastfeeding, Antiretroviral and Nutrition (BAN) Study, a prevention of mother-to-child transmission of HIV clinical trial in Lilongwe, Malawi. Six trained nurses counseled HIV-infected mothers to exclusively breastfeed for 24 weeks postpartum and to stop breastfeeding within an additional four weeks. Implementation data were collected via direct observations of 123 infant feeding counseling sessions (30 antenatal and 93 postnatal) and interviews with each nurse. Analysis included calculating a percent adherence to checklists and conducting a content analysis for the observation and interview data. Nurses were implementing the protocol at an average adherence level of 90% or above. Although not detailed in the protocol, nurses appropriately counseled mothers on their actual or intended formula milk usage after weaning. Results indicate that nurses implemented the protocol as designed. Results will help to interpret the BAN Study's outcomes.
AIDS education and prevention: official publication of the International Society for AIDS Education 05/2009; 21(2):141-55. · 1.51 Impact Factor
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Charles van der Horst,
Charles Chasela,
Yusuf Ahmed,
Irving Hoffman,
Mina Hosseinipour,
Rodney Knight,
Susan Fiscus,
Michael Hudgens,
Peter Kazembe,
Margaret Bentley,
Linda Adair,
Ellen Piwoz,
Francis Martinson,
Ann Duerr, Athena Kourtis,
A Edde Loeliger,
Beth Tohill,
Sascha Ellington,
Denise Jamieson
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ABSTRACT: In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials is a complicated and lengthy process often requiring alterations to the original research design. Many factors lead to delays and changes, including study site-specific priorities, new scientific information becoming available, the involvement of national and international human subject committees and monitoring boards, and alterations in medical practice and guidance at local, national, and international levels. When planning and implementing a clinical study in a resource-limited setting, additional factors must be taken into account, including local customs and program needs, language and socio-cultural barriers, high background rates of malnutrition and endemic diseases, extreme poverty, lack of personnel, and limited infrastructure. Investigators must be prepared to modify the protocol as necessary in order to ensure participant safety and successful implementation of study procedures. This paper describes the process of designing, implementing, and subsequently modifying the Breastfeeding, Antiretrovirals, and Nutrition, (BAN) Study, a large, on-going, randomized breastfeeding intervention trial of HIV-infected women and their infants conducted at a single-site in Lilongwe, Malawi. We highlight some of the successes, challenges, and lessons learned at different stages during the conduct of the trial.
Contemporary clinical trials 10/2008; 30(1):24-33. · 1.51 Impact Factor
