Women Shortchanged in HIV Research

Although women represent almost half of the people living with HIV, men still make up the majority of the subjects used in HIV research, a new study has shown. Some HIV research funded by the U.S.. National Institutes of Health (NIH) had a particularly low rate of women subjects, the study found.

“There is an urgent need to ensure that HIV clinical studies consider sex/gender dimensions,” Mirjam J. Curno, PhD an editor at Frontiers in Lausanne, Switzerland who was formerly of the International AIDS Society in Geneva. Curno and colleagues reviewed existing literature to reach their findings.

Dissimilarities in body surface, hepatic function, drug metabolism and clearance are among the pharmacokinetic and pharmacodynamic differences that can cause different treatment responses in women, the study explained. Also, men and women have other differences in terms of economic power, health literacy, health-seeking behavior and access to healthcare services, the study added.

This international literature review found wide ranging differences in the proportion of women research subjects, depending up on the type of clinical study, funding source, and the income level of the country where the study was conducted.

In studies on antiretroviral drugs (ARV), where the median percentage of female subjects was 19.2 percent, there was a variance according to funding source. ARV studies funded wholly or in part by the NIH had a median of 19.6 percent, the study said. Publicly funded ARV studies had the lowest proportion of women participants, 16.7 percent, while private and non-commercially funded studies had the highest median rate of 29.2 percent.

The percentage of women participating in NIH sponsored studies is of interest because of the 1993 National Institutes of Health Revitalization Act that required the Institute to make sure the clinical trials it sponsored were designed to include meaningful sex and gender-based assessments. That policy was updated in 2001.

Curative strategy (CURE) and prophylactic vaccine (VAX) studies had median female participation rates of 11.1 percent and 38.1 percent. In those studies the range of women participants did not correlate with funding sources.

Where studies were conducted in high income countries alone, fewer women were enrolled in ARV and CURE research, the study reported, while fewer women in low income countries participated in VAX studies.

The authors listed several possible reasons why clinical trials and other research used a lower proportion of female subjects. Among the reasons were the disparities in the incidence of HIV in women in high- and low-income countries. More women in low-income countries are infected with HIV than in high-income countries. The proportions are the opposite in high-income countries, such as the U.S.. where HIV infects more men, especially men who have sex with men, the study explained.

The study also made suggestions for strategies that could raise the proportion of female HIV research subjects: making long-term birth control available, engaging community advocates and advisors at research sites, tailoring recruitment strategies to women.

The literature review was based on search of articles indexed by PubMed for dates differing by the study category (ARV, CURE and VAX) and ranging overall from 1995 to 2012.

“Only with sufficient knowledge of sex and gender differences and similarities can optimal and evidence-based treatment, prevention, and care be delivered to both women and men living with or at risk for HIV,” the authors concluded.

The study appeared in the Feb. 1 issue of JAIDS, Journal of Acquired Immune Deficiency Syndrome