ASPIRE: Women report use of vaginal ring for HIV prevention has little effect on sex

Most women from the ASPIRE study who used vaginal rings containing dapivirine to prevent HIV infection said the ring did not have a negative effect on their sex life, according to a press release.

“Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in the release. “Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”

Anthony S. Fauci

In the MTN-020/ASPIRE study, 2,629 women aged 18 to 45 years from 15 sites in Malawi, Uganda, Zimbabwe and South Africa randomly received either a monthly ring containing 25 mg of the non-nucleoside reverse transcriptase inhibitor dapivirine, or placebo. According to data presented at CROI 2016, there were 71 HIV infections among women assigned the dapivirine ring (3.3 per 100 person-years) vs. 97 infections among those given placebo (4.5 per 100 person-years), which translated to a 27% relative reduction (95% CI, 1-46). Further analysis showed the ring reduced the risk for infection by at least 56% among women with greater adherence, and up to 75% among those who consistently used the ring, per the release.

For a separate analysis, Nicole Laborde, PhD, MPH, of RTI International in Research Triangle Park, North Carolina, and colleagues examined data on 214 participants who responded to questions regarding their sexual experiences while using the ring. According to the results presented at the HIV Research for Prevention meeting, most women said the ring did not have a large impact on sexual intercourse. Some women reported greater sexual satisfaction with the ring, due in part to perceived protection. Others, however, were concerned with how their partners would react if they knew about the ring and either removed it before engaging in sexual intercourse or limited their sexual activities. 

In an additional analysis, Thesla Palanee-Phillips, M.Med.Sci, PhD, MSc, co-chair of the ASPIRE study and director of Network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, and colleagues found that a small group of women (less than 5%) who reported intimate partner violence or other social harms within 1 month of the interview were nearly 2.5 times more likely to have low adherence.

According to the NIAID, some women at risk for social harm and violence may choose not to disclose use of HIV protection to their sexual partners. Although most women in the MTN-020/ASPIRE study revealed use of the ring to their male partners, 13% chose not to disclose this information. Researchers found this decision had no impact on ring adherence.  

“Sub-Saharan African women have a broad range of sexual experiences and relationship dynamics, and we are learning more about how these diverse behaviors and circumstances influence the use of the ring,” Palanee-Phillips said in the release. “While we have found that most women do disclose ring use to their primary partners, it is reassuring that adherence is not affected for the significant minority of women who choose to use it more discreetly.”

Other concerns regarding ring use, health, hygiene, sexual enjoyment and social approval decreased between the start and end of the trial. Notably, 29% of women at the start of the trial said they were worried about having the ring inside their bodies for at least a year and only 4% had this concern at the trial’s conclusion.

According to the release, researchers from the HOPE study will continue to collect quantitative and qualitative data to further investigate whether women prefer to use the ring over pre-exposure prophylaxis for HIV prevention, and why.

References:

Baeten JM, et al. Abstract 109LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.

Baeten JM, et al. New Engl J Med. 2016;doi:10.1056/NEJMoa1506110.

Laborde, N, et al. The Influence of the Vaginal Ring on Sexual Experiences of Women in an HIV Prevention Clinical Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Palanee-Phillips T, et al. Frequency of Partner-related Social Harms and their Impact on Adherence to the Dapivirine Vaginal Ring during the MTN020/ASPIRE HIV Prevention Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Van der Straten A, et al. Are Ring Worries Affecting Use? Findings from the MTN-020/ASPIRE Phase III Dapivirine Ring Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Disclosures: Fauci reports no relevant financial disclosures. Infectious Disease News was unable to confirm other disclosures at the time of publication.

Most women from the ASPIRE study who used vaginal rings containing dapivirine to prevent HIV infection said the ring did not have a negative effect on their sex life, according to a press release.

“Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in the release. “Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”

Anthony S. Fauci

In the MTN-020/ASPIRE study, 2,629 women aged 18 to 45 years from 15 sites in Malawi, Uganda, Zimbabwe and South Africa randomly received either a monthly ring containing 25 mg of the non-nucleoside reverse transcriptase inhibitor dapivirine, or placebo. According to data presented at CROI 2016, there were 71 HIV infections among women assigned the dapivirine ring (3.3 per 100 person-years) vs. 97 infections among those given placebo (4.5 per 100 person-years), which translated to a 27% relative reduction (95% CI, 1-46). Further analysis showed the ring reduced the risk for infection by at least 56% among women with greater adherence, and up to 75% among those who consistently used the ring, per the release.

For a separate analysis, Nicole Laborde, PhD, MPH, of RTI International in Research Triangle Park, North Carolina, and colleagues examined data on 214 participants who responded to questions regarding their sexual experiences while using the ring. According to the results presented at the HIV Research for Prevention meeting, most women said the ring did not have a large impact on sexual intercourse. Some women reported greater sexual satisfaction with the ring, due in part to perceived protection. Others, however, were concerned with how their partners would react if they knew about the ring and either removed it before engaging in sexual intercourse or limited their sexual activities. 

In an additional analysis, Thesla Palanee-Phillips, M.Med.Sci, PhD, MSc, co-chair of the ASPIRE study and director of Network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, and colleagues found that a small group of women (less than 5%) who reported intimate partner violence or other social harms within 1 month of the interview were nearly 2.5 times more likely to have low adherence.

According to the NIAID, some women at risk for social harm and violence may choose not to disclose use of HIV protection to their sexual partners. Although most women in the MTN-020/ASPIRE study revealed use of the ring to their male partners, 13% chose not to disclose this information. Researchers found this decision had no impact on ring adherence.  

“Sub-Saharan African women have a broad range of sexual experiences and relationship dynamics, and we are learning more about how these diverse behaviors and circumstances influence the use of the ring,” Palanee-Phillips said in the release. “While we have found that most women do disclose ring use to their primary partners, it is reassuring that adherence is not affected for the significant minority of women who choose to use it more discreetly.”

Other concerns regarding ring use, health, hygiene, sexual enjoyment and social approval decreased between the start and end of the trial. Notably, 29% of women at the start of the trial said they were worried about having the ring inside their bodies for at least a year and only 4% had this concern at the trial’s conclusion.

According to the release, researchers from the HOPE study will continue to collect quantitative and qualitative data to further investigate whether women prefer to use the ring over pre-exposure prophylaxis for HIV prevention, and why.

References:

Baeten JM, et al. Abstract 109LB. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.

Baeten JM, et al. New Engl J Med. 2016;doi:10.1056/NEJMoa1506110.

Laborde, N, et al. The Influence of the Vaginal Ring on Sexual Experiences of Women in an HIV Prevention Clinical Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Palanee-Phillips T, et al. Frequency of Partner-related Social Harms and their Impact on Adherence to the Dapivirine Vaginal Ring during the MTN020/ASPIRE HIV Prevention Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Van der Straten A, et al. Are Ring Worries Affecting Use? Findings from the MTN-020/ASPIRE Phase III Dapivirine Ring Trial. Presented at: HIV Research for Prevention; Oct. 17-21, 2016; Chicago

Disclosures: Fauci reports no relevant financial disclosures. Infectious Disease News was unable to confirm other disclosures at the time of publication.