Adherence to rectal microbicide use among mainly ethnic minority young MSM: lessons from a 3-month placebo gel trial at three US sites [IAS 2013]

Oral paper presented by Alex Carballo-Diéguez at IAS 2013.

 

Click for slides.

Abstract:

Background: Adherence to product use is the cornerstone of microbicide studies. This is the first study to assess how frequently mainly ethnic minority MSM, ages 18-30, with a history of unprotected receptive anal intercourse (RAI) in the prior year, would self-administer gel using a rectal-specific applicator prior to RAI in their everyday lives.

Methods: Recruitment took place in Boston, MA; Pittsburgh, PA, and San Juan, PR. Participants received 40 applicators prefilled with 4mL of hydroxyethylcellulose placebo gel that they could use over 12 weeks. They were asked to self-administer a dose within 90 minutes prior to RAI and report RAI and gel use at least weekly through an interactive voice response system (IVRS). At week 12, they responded to a Computer Assisted Self Interview (CASI) and underwent an in-depth interview. Participants were repeatedly counseled that the study focused on product adherence and that the gel would not protect against HIV.

Results: 124 MSM were enrolled (Mean age 23.1; 41% White, 40% Latino, 8% African American, 11% mixed/other). 95 participants completed the trial (18 were lost to follow up and 11 withdrew). Based on the IVRS, (n=94, 1 missing data), 88 participants had RAI (Median 10 occasions) using gel on 81.1% of occasions (SD 23.3, range 0-100). Based on CASI, (n=86, 9 refused to answer RAI question) 83 participants had RAI (Median 12 occasions) using gel on 81.7% of occasions (SD 26.7; 0-100). Based on CASI, 69% of men typically applied gel immediately before RAI; 40 inconsistent users gave as reasons not having gel with them (85%), forgetting to use it (48%), not wanting to use it (13%), partner refusal (10%) and gel messiness (10%).

Conclusions: Ethnically diverse young MSM with a history of unprotected RAI showed high adherence to gel use. Adherence to product use could potentially be enhanced by improving portability, facilitating the development of routines to counteract forgetfulness, and improving motivation and partner negotiation skills. Participant retention was challenging and needs further study. Two different self-report methods provided convergent results. Limitation: A product of known efficacy could have different uptake than the placebo used in this study.


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PrEP: A Possible Approval Like No Other

Via Poz, by Tim Horn

The AIDS Healthcare Foundation began a paid advertisement campaign urging Gilead Sciences to refrain from seeking approval from the U.S. Food and Drug Administration for Truvada for use of the combination tablet as HIV prevention, in an approach known as pre-exposure prophylaxis, or PrEP.

The ads were met by an outcry from the community. One prominent organization, the HIV Prevention Justice Alliance, issued a sign-on letter , dated March 16, urging the FDA "to examine the study results of PrEP rather than playing to speculation and fear."

While I agree that PrEP should be considered as an option in the HIV prevention toolkit and would ultimately support an effort by Gilead to expand Truvada's labeling to include PrEP--should the company petition the FDA for approval--I am also of the mind that a green light from the FDA should not be met with the rush-to-treatment that typically follows approval of a drug.

Given how little we know about the safe application of PrEP in a real-world setting--read: outside of a clinical trial--not to mention the expense of a comprehensive prevention program that includes PrEP, I think more feasibility studies need to take place before we consider a widespread HIV prevention program involving PrEP.

Here's what we do know: PrEP is effective in one population of at-risk individuals: men who have sex with men (MSM). The iPrEx clinical trial, sponsored by the National Institute of Allergy and Infection Diseases (NIAID) of the U.S. National Institutes of Health (NIH) and co-funded by the Bill & Melinda Gates Foundation, involved a large sample size (approximately 2,500) of MSMs. The study, which had sound design and statistical analysis, proved Truvada use resulted in significantly fewer infections compared with those using a placebo.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Debate PrEP based on facts

Via Ebar, by Dr. Robert Grant

A robust public debate is under way about the potential use of anti-HIV drugs to prevent HIV infection (also known as pre-exposure prophylaxis or PrEP). Our study, called iPrEx, provided the first conclusive evidence that the daily use of PrEP with the FDA-approved HIV treatment Truvada can significantly reduce HIV infection risk in gay, bisexual, and other men who have sex with men and transgender women, when delivered as part of a comprehensive package of prevention services, including condoms.

Recently, a private health care provider has begun a paid advertising campaign urging the FDA not to even consider approving the use of PrEP – charging, among other things, that MSM will stop using condoms if PrEP is permitted. The pros and cons of PrEP use should be vigorously debated – but that debate should be based on facts, rather than the assumption that MSM will not act to protect themselves and others from infection. Here are the facts about the iPrEX study:

The protection provided by PrEP and condoms together could have a substantial impact in reducing new HIV infections among MSM worldwide.

A diverse group of 2,499 HIV-negative MSM and transgender women on four continents with a range of sexual practices participated in iPrEx. All participants received a comprehensive package of HIV prevention services. Half also received Truvada, while the other half received a placebo (blank pill). Neither the study participants nor the investigators knew which pill they received during the study.

Men in both study groups reduced their risk behaviors and increased their condom use – demonstrating that MSM can use PrEP and condoms together. PrEP does not protect against other sexually transmitted infections and should never be considered as a substitute for condom use or other safer sex precautions.

Much more work lies ahead to determine whether PrEP can help stop HIV infections in other populations, such as heterosexuals and injection drug users, to better understand possible side effects of PrEP, to support consistent pill use among people who want to use it, and to ensure that PrEP is seen as one element of an HIV prevention strategy that includes regular condom use.

Additional studies are also under way to test whether other anti-HIV medicines (including pills, gels, and other formulations) are safe and effective for HIV prevention.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]