Lower adherence among black gay youth
A US study pre-exposure prophylaxis (PrEP) in 200 gay men and bisexual young people aged between 18-22 found reasonable levels of grip. Adherence was higher among those with higher risk of HIV INFECTION.
However, the study found that adherence fell considerably after study visits changed from monthly to quarterly, suggesting that young gays using PrEP could benefit from more intense support than older participants. It has also been shown that there is considerably less adherence among young blacks and mestizos.
"This is a group of young people of whom very few have health insurance or visit health services on a regular basis. Further research is needed on the health beliefs and confidence levels of our participants in order to understand what can support the consistent use of PrEP, "said Dr. Hosek
ATN (National Network of Trials with Adolescents) 110 is one of a series of studies that investigated the safety and viability of PrEP in young male homosexuals. A previous ATN 082 pilot study, It was reported in aidsmap in 2013. A third study, ATN 113, which looks like PrEP in adolescents aged 15-17, is attached to the report to be presented in 2016.
Sibyl Hosek of Stroger of Cook County Hospital in Chicago told Eighth International AIDS Society Conference on HIV Pathogenesis, Tratratamento and Prevention (IAS 2015) that men who have sex with men (MSM in English, or MSM in Portuguese) aged 13-24 were the hardest hit by the US HIV epidemic but were not represented in the PrEP studies.
ATN 110 has been performed at clinics in twelve cities across the United States. The eligibility criteria included people who had had anal sex without condoms in the last six months with a partner who was HIV-positive or had HIV status unknown; Unprotected sex (no condom) with more than three sexual partners in the last six months; sex in exchange for gifts or money; and sex with a partner diagnosed with a sexually transmitted disease (STD).
Initially, candidates for the study registered interest in the online version or during visits to local health services. More than 2.000 men were initially contacted in the pre-selection phase, but 42% decided they were not interested and 40% did not meet the eligibility criteria.
This made 400 eligible. Of these, 123 decided at this stage they did not want to participate, leaving 277 remnants that were invited to participate in a screening visit. Of these, 34 did not show up or lost contact, 15 were excluded for medical reasons and 11 (4,4% of screened) were diagnosed as HIV positive. This left 200 subjects, of which 142 attended the study throughout its course. Thirty-five have lost track, which is actually a small part of this highly mobile population. Twenty-five participants (12,5%) decided to stop using PrEP during the study because of gastrointestinal, side effects.
The average age of 200 enrolled was 20 years, 78% identified themselves as gay and the rest declared themselves bisexual, 30% were unemployed, and a third had not attended school beyond the 16 years. One in six said they had been expelled from the home, and 29% had been paid for sex. Fifty-three percent were black, 17% were Hispanic and 21% white, mixed with Asians and Pacific Islanders.
The average number of partners they had last month was five: 81% had unprotected sex in the last six months; in 58% of participants, their last sexual intercourse had served as passive partners in the relationship with anal sex. Over 20% tested positive for an STD in the past.
Participants did not receive PrEP immediately. First, they did a seven-week behavioral test, designed to strengthen self-care and behavioral assertiveness (Many men, many voices), or the equivalent number of behavioral / cognitive orientation sessions. Only after this did they receive PrEP. They were not randomized for the interventions, since the clinics involved in the study were already offering one or other of these two interventions.
Adhesion to PrEP was initially good, with only 60% of participants with blood levels of the drug above the level indicating that at least four doses per week were being taken systematically, which is considered to be fully protective.
The second monthly visit 95% of subjects had evidence of having at least some PrEP uses.
However adherence level decreased noticeably after the 12X week of the study of 48 weeks, when outpatient visits changed from monthly to quarterly. At the end of the study, only 35% of participants were taking at least four doses per week and 30% showed no signs of having PrEP on every day.
There was a clear racial cleavage of adherence. White and Latino participants maintained the mean of more than 700 ng / ml tenofovir in their blood throughout the study, an equivalent level of + 4 doses per week. In contrast to the black participants who, on average, never managed to reach the level of more than four doses per week and at the end of the study the levels of the median drug in black participants was very little above zero, indicating that very little use of PrEP happened .
Dr. Hosek commented: "This is a group of young people of whom very few have health insurance or go to a health clinic regularly. Further research is needed on the health beliefs and confidence levels of our participants in order to understand what PrEP can withstand. "
One participant was diagnosed as HIV positive in the month of their first visit to the medical center and had been in their "immunological window." This was not counted as an HIV infection within the study.
There were four infections in the participants during the study, at weeks 8, 32, 40 and 48, providing an annual incidence rate of participants of 3,29% per year. All four of these had taken PrEP at some point but had no detectable levels of tenofovir in their blood at the study visit where HIV was diagnosed. The last man to be infected, at 48th week, maintained protective levels of PrEP up to the middle of the study, and then started taking PrEP doses less often; the other three had difficulties with membership from the outset.
Forty percent of the participants had an STD in the last 24 weeks of the study; there was a refusal to PrEP of 30% at weeks 24 and 48 of the study, although this decrease was not statistically significant. The number of male sexual partners without a condom had dropped from five in the last month to three after the first visit and did not increase. This was also not statistically significant, nor was there any other change in risk behavior, whatever the number of partners the participants had, or the proportion with which they had engaged in unprotected receptive anal sex.
However, participants who reported engaging in sex without condoms had the highest levels of tenofovir at all study visits, indicating that the use of PrEP was related to perceived risk (p = 0,005).
"The ATN 110 Study was successfully triggered for young men who had sex with other men who would be eligible for PrEP," commented Dr Hosek.
"The incidence rate of HIV was high compared with open arms in other PrEP trials, but given the high number of STDs incident is likely to have been even greater in the absence of Prep."
Published by Gus Cairns in 24 July of 2015 in Gay youth PrEP study finds good retention and reasonable adherence
Hosek S et al. An HIV pre-exposure prophylaxis (PrEP) demonstration project and safety study for young men who have fri with men in the United States (ATN 110). Eighth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015), Vancouver. Abstract in TUAC0204LB. 2015.
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