Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.

Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3). Understanding of research concepts and study procedures was assessed immediately postintervention and at 1-week follow-up. At postintervention, participants in groups 2 and 3 understood more about research concepts and study procedures compared with group 1. Group 3 participants also understood more about study procedures compared with group 2. At follow-up, participants in groups 2 and 3 continued to understand more about research concepts and study procedures. Context-specific approaches improved understanding of consent information in this study.

Prevention of mother-to-child transmission: program changes and the effect on uptake of the HIVNET 012 regimen in Malawi.

OBJECTIVE(S): To evaluate uptake of HIV testing in a prevention of mother-to-child transmission program (PMTCT) in Lilongwe, Malawi from April 2002 until December 2006. DESIGN: Retrospective analysis of monthly reports from the beginning of the program. SETTING: Four antenatal clinics in Lilongwe, Malawi. METHODS: Pregnant women attending urban antenatal clinics in Lilongwe were invited to participate in a PMTCT program. Women were given information and education on antenatal care and PMTCT in groups of 8 to 12. Written informed consent for HIV testing was obtained privately. Women returned for the test result 1-2 weeks later. Mothers and infants were given the HIVNET 012 regimen. Rapid HIV testing and 'opt-out' testing were instituted in July 2003 and April 2005, respectively. Infants were tested using HIV DNA PCR and, if HIV positive, a CD4 cell percentage was obtained and the infants were referred for further medical evaluation and treatment. RESULTS: The program reached 20 000 pregnant women in the first 12 months. Acceptance of HIV testing increased from 45% to 73% (P < 0.001) when rapid, same day testing was instituted. When opt-out testing was instituted, 99% of the mothers agreed to testing. Of the infants tested, 15.5% were HIV positive. CONCLUSION: Rapid HIV testing using the opt-out method increased acceptance of HIV testing in the PMTCT program to 99% in urban Lilongwe, Malawi.

Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.

OBJECTIVE: To learn the attitudes and concerns of the local community on participating in research, infant feeding practices, and maternal nutrition in order to inform the design of a clinical trial in Lilongwe, Malawi on the safety and efficacy of antiretroviral and nutrition interventions to reduce postnatal transmission of HIV. DESIGN: Formative research methods were used, including semi-structured interviews, focus group discussions, home observations, and taste trials. Data were collected, analyzed, and incorporated into the protocol within 3 months. RESULTS: Participants were supportive of the clinical trial, although their overall understanding of research was limited. Mothers agreed that infants' blood could be drawn by venipuncture, yet concern was raised about the amount of blood proposed to be collected from both infants and mothers. Data demonstrated that rapid breastfeeding cessation would be difficult and malnutrition could be a risk if infants were weaned early. Mothers selected a maternal supplement suitable for use in the clinical trial. CONCLUSIONS: The protocol was rapidly modified to achieve cultural acceptability while maintaining study objectives. Without the formative research, several significant areas would have been undetected and may have jeopardized the implementation of the trial. Additional research was carried out to develop a meaningful informed consent process, the amount of blood collected was reduced to acceptable levels, and the protocol was modified to reduce the risk of malnutrition. Researchers who conduct clinical trials are encouraged to incorporate formative research into their protocol design to ensure participant understanding of the research, to safeguard participants, and to increase feasibility and acceptance of the clinical research in the community.

Differences between international recommendations on breastfeeding in the presence of HIV and the attitudes and counselling messages of health workers in Lilongwe, Malawi.

BACKGROUND: To prevent postnatal transmission of HIV in settings where safe alternatives to breastfeeding are unavailable, the World Health Organization (WHO) recommends exclusive breastfeeding followed by early, rapid cessation of breastfeeding. Only limited data are available on the attitudes of health workers toward this recommendation and the impact of these attitudes on infant feeding counselling messages given to mothers. METHODS: As part of the Breastfeeding, Antiretroviral, and Nutrition (BAN) clinical trial, we carried out an in-depth qualitative study of the attitudes, beliefs, and counselling messages of 19 health workers in Lilongwe, Malawi. RESULTS: Although none of the workers had received formal training, several reported having counseled HIV-positive mothers about infant feeding. Health workers with counselling experience believed that HIV-infected mothers should breastfeed exclusively, rather than infant formula feed, citing poverty as the primary reason. Because of high levels of malnutrition, all the workers had concerns about early cessation of breastfeeding. CONCLUSION: Important differences were observed between the WHO recommendations and the attitudes and practices of the health workers. Understanding these differences is important for designing effective interventions.

Using formative research to develop a context-specific approach to informed consent for clinical trials.

PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild transmission of HIV during breastfeeding, formative research was conducted to explore the community's understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research.

Perceptions of the role of maternal nutrition in HIV-positive breast-feeding women in Malawi.

A neglected issue in the literature on maternal nutrition and HIV is how HIV-positive women perceive their own bodies, health, and well-being, particularly in light of their infection, and whether these perceptions influence their infant feeding practices and their perceived ability to breast-feed exclusively through 6 mo. We conducted formative research to better understand breast-feeding practices and perceptions, and to inform the Breastfeeding, Antiretroviral, and Nutrition (BAN) Study, a clinical trial to evaluate antiretroviral and nutrition interventions to reduce mother-to-child transmission of HIV during breast-feeding in Lilongwe, Malawi. Twenty-two HIV-positive women living in semi-rural areas on the periphery of Lilongwe participated in in-depth interviews. In an adaptation of the body-silhouette methodology, nine culturally appropriate body silhouettes, representing a continuum of very thin to very large shapes, were used to elicit women's views on their present, previous-year, and preferred body shapes, and on the shape they perceived as healthy. The narrative scenario method was also used to explore women's views on 2 fictional women infected with HIV and their ability to exclusively breast-feed. Women perceived larger body shapes as healthy, because fatness is considered a sign of good health and absence of disease, and many recognized the role of nutrition in achieving a preferred or healthy body shape. Several women believed their nutritional status (body size) was declining because of their illness. Women were concerned that breast-feeding may increase the progression of HIV, suggesting that international guidelines to promote appropriate infant feeding practices for infants whose mothers are infected with HIV should focus on the mother's health and well-being, as well as the infant's.