Programming Connection

Project PrEPare 2 

CATIE

2017

An American demonstration project1 has shown that young gay, bisexual and other men who have sex with men (MSM) who have sex that may expose them to HIV in an ongoing way find the care and support related to taking pre-exposure prophylaxis (PrEP) acceptable. The study also showed that young MSM may experience significant challenges to adherence over time, suggesting young MSM may need intensive care and support while on PrEP.

Project PrEPare 2

Project PrEPare 2 was a PrEP demonstration project that recruited young MSM at 12 urban sites in the United States between January and September 2013.The objectives of the study were to:

  • add to the safety evidence of Truvada as PrEP among HIV-negative young MSM
  • examine acceptability of, patterns of use of, rates of adherence to PrEP, and drug blood levels
  • examine patterns of risk behaviour when young MSM are provided with an evidence-based behaviour intervention before PrEP initiation (Many Men, Many Voices (3MV) or Personalized Cognitive Counselling (PCC))

Young men were eligible for the study if they were:

  • born male
  • between the ages of 18 and 22
  • HIV negative at the time of screening
  • reported HIV transmission risk behaviour

Participants participated in either 3MV or PCC depending on the study site. Once the behavioural intervention was completed, participants were scheduled for their first visit. At this visit they received additional PrEP education and were given a 30-day supply of Truvada.

Participants returned for clinic visits every four weeks for the first three months of the study and then every three months for the rest of the 12-month study period. At each visit, a medical history was taken for signs and symptoms of any illness, and a symptom-directed physical exam was conducted. Behavioural data was also collected.

At every visit, participants were tested for HIV, hepatitis B, gonorrhea, and chlamydia; kidney, liver, and pancreas function; and for adherence to PrEP through dried blood spots. Rectal swabs for chlamydia and gonorrhea were collected at baseline, six months and 12 months or when clinically indicated. Syphilis tests were conducted at baseline and then at the end of the study, unless symptoms were observed. Participants also received a comprehensive HIV prevention package that included risk reduction counselling, condoms, sexually transmitted infection (STI) screening and treatment, and met with a counsellor.

Who participated in Project PrEPare 2?

Two hundred young MSM were enrolled in the study. The median age was 20. Sixty-six percent of participants identified as Black, 29% identified as White, and 26% identified as Latino. Most participants identified as gay (78%) or bisexual (14%). Thirty percent were unemployed, 29% had ever exchanged sex for money, and 15% had ever been homeless. Study retention was 71%.

PrEP safe in young MSM

The study showed that side effects such as nausea, weight loss and headache associated with Truvada resolved when the drug was discontinued. A small but significant decrease in bone mineral density was observed among participants. There was no harm to participants’ kidneys.

PrEP care acceptable to young MSM

Over 90% of participants said they liked PrEP care (or liked it a lot) during the study, including regular STI testing, physical exams, and counselling. Sixty percent found taking the Truvada pill every day acceptable.

Adherence to PrEP decreased as time between clinic visits increased

Truvada was detectable in the blood of 90% of participants through the first three months of the study. This decreased to 81% six months into the study, and decreased again to 69% at the end of the study.

Although 69% of participants had detectable levels of Truvada in their blood at the end of the study, only 34% had a protective level of Truvada in their blood. Median levels of Truvada in the blood of Black participants were below the protective level at each time point in the study.  

The most common reasons for low adherence among all participants were forgetting (29%), travelling (27%), and being busy (27%).

STI rates remained high

Twenty-two percent of participants were diagnosed with an STI at the start of the study. Overall, STI diagnoses remained high over the course of the study with an incidence rate of 66 per 100 person years.

HIV seroconversions

Four men seroconverted during the study; none had detectable levels of Truvada in the blood sample drawn closest to their seroconversion.

What does this mean for Canadian service providers?

The Project PrEPare 2 study showed that young MSM who have sex that may expose them to HIV in an ongoing way find PrEP care acceptable. However, the study found that young MSM find adherence challenging, especially when the time between visits was increased from one month to three. More frequent clinical visits may be optimal care for young MSM on PrEP.

Service providers offering PrEP care and support may want to tailor support programs to clients—including culturally competent and age-tailored programs—as ways to improve rates of adherence among younger MSM.

Reference

Hosek S, Landovitz R, Kapogiannis B, et al. An HIV pre-exposure prophylaxis (PrEP) demonstration project and safety study for young MSM. Journal of Acquired Immune Deficiency Syndromes. 2017 Jan 1;74(1):21-29.