Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.
The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP from prior studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
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. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Stroger Hospital and the CORE Center
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Fenway Institute
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
...and 2 more locations
Number of Participants With Serum Creatinine Event of Grade 1 or Higher
This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal.
Time frame: 48 Weeks
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM." The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48.
Time frame: 48 weeks
Lumbar Spine Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for lumbar spine.
Time frame: Baseline, Week 48
Femoral Neck Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for femoral neck.
Time frame: Baseline, Week 48
Total Body Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total body.
Time frame: Baseline, Week 48
Total Hip Bone Mineral Density at Baseline and at Week 48
This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM. Bone mineral density at Baseline and Week 48: data reported below for total hip.
Time frame: Baseline, Week 48
Number of Participants With Unprotected Sex Acts
This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to male partners in the past month/since the last survey: "Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month?" (Baseline), or "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?" (Week 48) An event is defined as an answer of greater than 0.
Time frame: Baseline and 48 weeks
Number of Sex Partners
This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey: "During the past month, how many male partners have you had sexual contact with (oral or anal)?" (Baseline), or "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" (Week 48) And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey: "Of those you had unprotected sex with, how many did you know were HIV positive?"
Time frame: Baseline and 48 weeks
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill
This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies" Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the taste of the pill.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill
This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies" Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about the color of the pill.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day
This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies." Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking the pill every day.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study
This outcome addresses the objective "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies." Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This specific outcome focuses on the question of how participants felt about taking part in the study.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit.
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit
Time frame: Week 12
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam
This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor
Time frame: Week 12
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
This outcome addresses the objective: "Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies." PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and \>1250 fmol per punch (daily).
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
This outcome addresses the objective: "Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies." PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 1 of 10: "I learned a lot from this workshop/session"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 2 of 10: "I will be able to apply what I learned from this workshop/session in my life"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 3 of 10: "I was given an opportunity to participate and discuss information with others"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 4 of 10: "The workshop/session was well organized"
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Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 5 of 10: "The topic of this workshop/session was interesting"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 6 of 10: "The presenter(s) stimulated my interest in the material"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 7 of 10: "The topic of this workshop/session was relevant to my life"
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 8 of 10: "The workshop/session was enjoyable."
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 9 of 10: "I would recommend this workshop/session to others."
Time frame: 48 weeks
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session."
Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session). Item 10 of 10: "I felt comfortable participating in this workshop/session."
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's age at enrollment.
Time frame: 48 weeks
Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (5 categories)
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's race (2 categories)
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's BMI (kg/m2), assessed categorically.
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)
Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use. PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not. This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
Total number of subjects who signed up for text message reminders
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
Number of subjects who discontinued receiving text message reminders while they were still on the study agent
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Were away from home?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Were too busy with other things?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Simply forgot?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Had too many study pills to take?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Wanted to avoid side effects?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Did not want others to notice you taking meds?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Had a change in daily routine?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Felt like the study pill was toxic/harmful?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Fell asleep/slept through dose time?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Felt sick or ill?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Felt depressed/overwhelmed?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Ran out of study pills?"
Time frame: 48 weeks
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)
Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48. Question: In the past month, how often have you missed taking your study pills because you: "Didn't think you needed it because you weren't having risk sex?"
Time frame: 48 weeks