Latest ASPIRE Vaginal Ring Data Speak to Women's Experiences

Heather Boerner

October 26, 2016

CHICAGO — For young African women at risk for HIV, prevention measures must address intimate-partner violence and sexual pleasure, according to two new analyses of data from ASPIRE, a study of an investigational vaginal ring that contains the antiretroviral dapivirine.

For prevention programs to be appealing, they must make "people feel strong, less anxious, more in control of their lives, and able to enjoy sex," said Jared Baeten, MD, PhD, vice chair of the Department of Global Health and codirector of the International Clinical Research Center at the University of Washington in Seattle, who is principle investigator of ASPIRE.

ASPIRE is an ongoing randomized, double-blind, placebo-controlled trial of women 18 to 45 years of age in Malawi, South Africa, Uganda, and Zimbabwe.

A previous analysis from the ASPIRE researchers showed that the vaginal ring, inserted once every 4 weeks for 24 months, lowered the rate of HIV infection by up to 56% in African women (N Engl J Med. Published online February 22, 2016). However, for study participants 21 years and younger — who are at highest risk for HIV — adherence was poor.

To assess the causes of poor adherence in these young women, Dr Baeten and his colleagues looked at the potential effects of intimate-partner violence and social harms.

The results were presented here at HIV Research for Prevention 2016. Thesla Palanee-Phillips, PhD, from Wits Reproductive Health and HIV Institute in Johannesburg, reported data from the violence analysis.

Prevention strategies should make people feel strong, less anxious, more in control of their lives, and able to enjoy sex.

Of the 2629 study participants, 85 reported physical or emotional abuse inflicted by a partner or family member related to ring use — an incidence of less than 5%. However, 29% of those incidents resulted in physical harm, which 10% of the women characterized as having a major impact on their lives.

The women who experienced abuse were more likely to be nonadherent to vaginal ring use even before the abuse, which suggests that there was "a baseline level of fear" in these women, Dr Palanee-Phillips pointed out.

Age was the only factor significantly associated with harm; women who experienced violence were 3.8 times more likely to be younger than 21 years.

The good news is that, when women disclosed the abuse and received counseling on how to talk to their partners or cope with fear, adherence levels rose.

"The white coat can sometimes get in the way, but when there's trust between the provider and patient, it can make a difference in women's lives," Dr Palanee-Phillips explained.

Causative associations between abuse and adherence cannot be drawn from this analysis, which had no placebo group, said Barbara Friedland, MPH, from the Population Council in New York City.

And intimate-partner violence is common and often goes unreported, said Kawango Agot, PhD, from the Impact Research and Development Organization in Kenya, who works on empowerment programs for young women related to HIV.

She explained that when she and her colleagues ask young women why they don't report violence, they hear, "Oh, he did what he does all the time."

"As far as they are concerned, this is nothing to write home about," Dr Agot pointed out.

Results from this analysis raise the question of whether clinicians should assess social harms at quarterly visits, said Anna Forbes, a consultant who works with the US Women and Pre-Exposure Prophylaxis (PrEP) Working Group, a coalition of women from leading AIDS and women's health organizations. "It absolutely should be part of the guidelines," she said.

The effect of the inclusion of risk for social harms in adherence counseling will be assessed in the HIV Open-Label Prevention Extension, known as HOPE, a planned follow-on to ASPIRE.

Impact of the Vaginal Ring on Women's Sexual Experience

The second analysis of ARPIRE data, on whether use of the ring can affect a woman's sex life, was presented by Nicole Laborde, PhD, from RTI International in San Francisco.

In a demographically representative cohort of 214 women, the vaginal ring, for the most part, had no impact.

Women didn't feel the ring, and their partners didn't feel the ring, either.

"Women didn't feel the ring, and their partners didn't feel the ring, either," Dr Laborde explained.

A sizable minority of women chose to forgo digital or oral sex or to avoid some sex positions to prevent a partner from noticing the ring. However, fears often dissipated during the course of the study, and both male and female partners became less concerned about the ring.

Another sizable minority of women reported that they, their partners, or both perceived a change in the vaginal environment during sex that increased pleasure. "This is an interesting finding," Dr Laborde said. "It's been noted previously that wearing the vaginal ring can increase lubrication in the vagina."

Going forward, HIV research in Africa and in the United States must include questions about sexual health, including sexual satisfaction, said Marsha Martin, DSW, from the Global Network for Black People Working in HIV in Washington, DC, who has worked with public health departments to scale up HIV outreach.

If an HIV prevention measure "will help me enjoy a level of pleasure and control over my pleasure, I might do that," she said. Discussion of pleasure in HIV risk counseling, she added, is "absent but it's necessary."

ASPIRE is funded by the National Institutes of Allergy and Infectious Diseases, National Institutes of Health, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr Baeten, Dr Palanee-Phillips, Ms Friedland, Dr Agot, Ms Forbes, Dr Laborde, and Ms Martin have disclosed no relevant financial relationships.

HIV Research for Prevention (HIVR4P) 2016: Abstracts OA20.03 and OA23.05. Presented October 20, 2016.


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