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PrEP study in young Gays find a good retention and reasonable grip

Lower adherence among black gay youth

Sybil Hosek at IAS 2015 photo © Marcus Rose / IAS

Sybil Hosek at IAS 2015 photo © Marcus Rose / IAS

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 membership fell considerably after the study visits change from monthly to quarterly, suggesting that young gay using PrEP could benefit from more intensive support that the elderly participants. It was also shown that there is a considerably lower adherence among blacks and mestizos young.

"This is a group of young people of which very few have health insurance or visit the health services regularly. We need to do more research 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 Testing with teenagers) 110 is one of a series of studies investigating the safety and feasibility of PrEP in young gay men. A previous pilot study ATN 082,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.

Sybil Hosek of Stroger Hospital of Cook County in Chicago, told delegates theEighth International AIDS Society Conference on HIV Pathogenesis, Tratratamento and Prevention (IAS 2015)men who have sex with men (MSM in English or in Portuguese MSM) aged 13-24 were the hardest hit by the US HIV epidemic, but which were not represented in studies of PrEP.

ATN 110 was conducted in clinics in twelve cities across the United States. Eligibility criteria included people who have unprotected anal sex in the last six months with an HIV-positive partner or serological HIV status unknown; unprotected sex (without a 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 reported interest in the online version or during visits to local health services. More than 2.000 men were initially contacted in the pre-selection, but 42% decided they were not interested and 40% did not meet the eligibility criteria.

That left 400 eligible. Of these, 123 decided at this stage they would not participate, leaving 277 remaining who were invited to attend a screening visit. Of these, 34 did not attend or have lost touch, 15 were excluded for medical reasons and 11 (4,4% of screened) were diagnosed as seropositive for HIV. That left 200 subject of which 142 attended the study throughout its route. Thirty-five no follow-up, which actually is a small part for this highly mobile population. Twenty-five participants (12,5%) have decided to stop using PrEP during the study due to side effects, mainly gastrointestinal.

The average age of subscribers was 200 20 years 78% identified themselves as gay and the rest declared himself bisexual, 30% were unemployed, and a third had not attended school beyond the 16 years. One in six said they had been kicked out, and 29% had been paid for sex. Fifty-three percent were black, 17% were Hispanic and 21% of whites, mixed with Asian and Pacific Islanders.

The average number of partners they had in the last month was five: 81% had unprotected sex in the last six months; in 58% of the participants, the last sexual relationship that involved had acted as passive partners in relation to anal sex. More than 20% tested positive for an STD in the past.

Participants were not given immediately PrEP. First, they did a seven-week behavioral, designed to strengthen self-care and behavioral assertiveness (Many men, many voices), Or the equivalent number of behavioral / cognitive orientation sessions. Only after this they received PrEP. They were not randomized for interventions, since involved in the clinical study were already offering one or other of these two interventions.

Adhesion to PrEP was initially good, with only 60% of participants with blood drug levels above the level which indicates that at least four doses per week were being taken systematically, which is considered as being fully protective.

The second monthly visit 95% of subjects had evidence of having at least some PrEP uses.

However grip level decreased significantly after 12ª week study of 48 weeks, while outpatient visits switched from monthly to quarterly. At the end of the study, only 35% of subjects were taking at least four doses per week 30% and showed no signs of having been PrEP every day.

There was a clear race cleavage of adhesion. Hispanic whites and participants maintained over the average 700 ng / ml in blood tenofovir during the study, an equal level of + de4 doses per week. In contrast to the black participants, on average, they were never able to reach the level of more than four drinks per week and at the end of the study the median of drug levels 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 which very few have health insurance or go to a health clinic regularly. You need to do more research on the health beliefs and confidence levels of our participants in order to understand what can support the use of PrEP. "

One participant was diagnosed as HIV positive in the month of their first visit to the medical center and had been in his "window period". This was not counted as an HIV infection within the study.

There were four infections in participants during the study, in the weeks 8, 32, 40 and 48, providing an annual incidence rate of participants in 3,29% per year. All four of these had taken PrEP at some point, but did not have detectable levels of tenofovir in the blood in the study visit where HIV was diagnosed. The last man to be infected in 48ª week, maintained protective levels of PrEP to the middle of the study and then had begun to take PrEP doses less often; the other three struggled with membership from the beginning.

Forty percent of the participants had an STD in the past 24 weeks of the study; there was a refusal PrEP 30% in 24 and 48 weeks of the study, although this decrease was not statistically significant. The number of sexual partners men without a condom had fallen five in the last three months, after the first visit and did not increase. What also was not statistically significant, nor was there any change in risk behavior, whatever has been the number of partners that participants had, or the proportion that they had practiced receptive anal sex without a condom.

However participants who reported having engaged in sex without condoms had the highest levels of tenofovir in all study visits, indicating that the use of PrEP was related to the perception of risk (p = 0,005).

"The study ATN 110 has been successfully triggered for the young men who had sex with men who would be eligible for PrEP," said 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."

Gus Cairms

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PublicadoporGus Cairns on July 24 2015 in Gay youth PrEP study finds good retention and reasonable adherence

Translated by Claudio Souza, reviewed by Mara Macedo in 31 / 07 / 2015.

You can download this slide show at this link.

Reference

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.

A webcast of this presentation is available on the conference YouTube channel.

Or you can watch it here. A request. If anyone passing through here have the interest to label these texts to Portuguese in Brazil, please, please contact.

Where available, you can view details of sessions, view abstracts, download presentation slides and find webcasts using the conference 'Programme at a Glance' tool.

You Can Also Download the PDF of the abstract book from the conference website.

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