Intervention: Ethephon
Trial phase: Phase 2
SMILES: O=P(O)(O)CCCl
Sex: Male
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP
Eligibility criteria:
Inclusion Criteria:

Willing and able to provide written informed consent;
Male gender at birth;
Age 15 years and 0 days through 17 years and 364 days, inclusive, at the time of signed informed consent;

Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;
Anal intercourse with 3 or more male sex partners during the last 6 months;
Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;
Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;
Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or
At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;
Tests HIV antibody negative at time of screening;
Willing to provide locator information to study staff;
Willing to take PrEP;
Willing to participate in behavioral intervention;
Reports intention not to relocate out of AMTU study area during the course of the study; and
Does not have a job or other obligations that would require long absences from AMTU study area (greater than 4 weeks at a time).

Exclusion Criteria:

Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;
Intoxicated or under the influence of alcohol or other drugs at the time of consent;
Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 113 Protocol Team if they are having difficulty making the judgment.);
History of bone fractures not explained by trauma;
Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;
Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min calculated based on bedside Schwartz formula: Glomerular filtration rate (GFR) = (0.413 x (height in centimeters)) / (serum creatinine in mg/dl)), or serum creatinine > upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
Confirmed ≥ Grade 2 hypophosphatemia at time of screening;
Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;
Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;
Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio (UP/C);
UP/C > 0.37 g/g at time of screening, regardless of urine dipstick protein result;
Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (<120 mg/dL) at time of screening;
A confirmed Grade ≥ 3 toxicity on any screening evaluations;
Known allergy/sensitivity to the study agent or its components;
Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;
Use of disallowed medications; or
Inability to understand spoken English.