Trial Outcomes & Findings for Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project) (NCT NCT02043015)

NCT ID: NCT02043015

Last Updated: 2018-09-17

Results Overview

The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-09-17

Participant Flow

Participants were recruited in Cape Town, South Africa between February 2015 and September 2015. Each participant was followed for one year.

To obtain the target enrollment of 80 HIV-negative and 20 HIV-positive participants, additional HIV-positive persons consented to participate but were not prospectively followed after the baseline visit. Fifteen participants were study stopped after baseline and not eligible for prospective follow-up to reach the target enrollment numbers.

Participant milestones

Measure	Recipients of HIV Prevention Services Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), men who have sex with men (MSM) and lesbian, gay, bisexual, and transgender (LGBT) sensitization training for staff and providers, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
Overall Study STARTED	115
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Measure	Recipients of HIV Prevention Services Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), men who have sex with men (MSM) and lesbian, gay, bisexual, and transgender (LGBT) sensitization training for staff and providers, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	4
Overall Study Removed once target enrollment reached	15
Overall Study Participant moved away from study city	4
Overall Study Incarceration	1

Baseline Characteristics

Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)

Baseline characteristics by cohort

Measure	Recipients of HIV Prevention Services n=115 Participants Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	115 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.3 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex/Gender, Customized Gender identification · Female	7 Participants n=5 Participants
Sex/Gender, Customized Gender identification · Male	99 Participants n=5 Participants
Sex/Gender, Customized Gender identification · Transgender	5 Participants n=5 Participants
Sex/Gender, Customized Gender identification · Other	1 Participants n=5 Participants
Sex/Gender, Customized Gender identification · Unknown or not reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Black African	89 Participants n=5 Participants
Race/Ethnicity, Customized Coloured	21 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	1 Participants n=5 Participants
Region of Enrollment South Africa	115 Participants n=5 Participants
HIV Status at Baseline Visit HIV-Positive at Baseline	35 Participants n=5 Participants
HIV Status at Baseline Visit HIV-Negative at Baseline	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This analysis includes all participants enrolled for prospective follow-up at baseline. Twenty of the participants tested HIV-positive at baseline, and the remaining 80 tested HIV-negative.

The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period.

Outcome measures

Measure	Recipients of HIV Prevention Services n=100 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Retention in the Cohort Participants attending the Month 3 Visit	88 Participants
Retention in the Cohort Participants attending the Month 6 Visit	84 Participants
Retention in the Cohort Participants attending the Month 12 Visit	87 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Of the 80 participants who were HIV-negative at the baseline visit, 60 were PrEP-eligible based on behavioral and clinical criteria. At the Month 3 visit, participants who were not already on PrEP could be assessed for PrEP eligibility again. Participants could be counted as PrEP-eligible at both the Baseline and Month 3 time points.

Uptake of PrEP by study participants was measured as the number and percentage of enrolled participants eligible for PrEP at the baseline and 3-month study visits who choose to initiate PrEP at a visit one month later.

Outcome measures

Measure	Recipients of HIV Prevention Services n=60 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Use of PrEP PrEP Uptake at Month 1 Visit	39 Participants
Use of PrEP PrEP Uptake at Month 4 Visit	6 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The population includes all participants who were HIV-negative at baseline.

Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.

Outcome measures

Measure	Recipients of HIV Prevention Services n=80 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Number of Participants With New HIV Infection	6 Participants

SECONDARY outcome

Timeframe: Months 3, 6, and 12

Population: This analysis includes all participants enrolled for prospective follow-up at baseline.

Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit.

Outcome measures

Measure	Recipients of HIV Prevention Services n=120 Sex partners Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Condom Use Month 3 Visit	84 Sex partners
Condom Use Month 6 Visit	82 Sex partners
Condom Use Month 12 Visit	84 Sex partners

SECONDARY outcome

Timeframe: Months 3, 6, and 12

Population: This analysis includes all participants enrolled for prospective follow-up at baseline who self-reported using a condom during their most recent anal sex reported.

Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act.

Outcome measures

Measure	Recipients of HIV Prevention Services n=53 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Lubricant Use Month 3 Visit	17 Participants
Lubricant Use Month 6 Visit	14 Participants
Lubricant Use Month 12 Visit	9 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants who tested HIV-negative at baseline and were enrolled for prospective follow-up.

VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study.

Outcome measures

Measure	Recipients of HIV Prevention Services n=80 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake VCT during 12 months preceding the study period	57 Participants
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake VCT as part of the study	76 Participants
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake VCT outside of the study (during study period)	53 Participants
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake CVCT during the study period	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: This analysis includes all participants enrolled for prospective follow-up at baseline.

The number of HIV tests per participant administered during the study period.

Outcome measures

Measure	Recipients of HIV Prevention Services n=100 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Number of HIV Tests During Study	4.9 HIV tests Standard Deviation 3.0

SECONDARY outcome

Timeframe: Month 3, 6, and 12

Population: The analysis population includes all prospectively followed participants who completed the survey.

Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit.

Outcome measures

Measure	Recipients of HIV Prevention Services n=100 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Serodiscordant Unprotected Anal Intercourse (UAI) Month 3 Visit	11 Participants
Serodiscordant Unprotected Anal Intercourse (UAI) Month 6 Visit	5 Participants
Serodiscordant Unprotected Anal Intercourse (UAI) Month 12 Visit	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants who tested HIV-negative at baseline and were followed prospectively.

Measured as the number of men who report an eligible exposure who accept and initiate PEP.

Outcome measures

Measure	Recipients of HIV Prevention Services n=80 Participants Men receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and Pre-exposure prophylaxis with FTC/TDF
Acceptability of Post-exposure Prophylaxis (PEP)	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The mandatory MSM-specific training had already been completed for health care providers in Cape Town, thus the training specified by the study protocol was no longer necessary.

Measured as the number of providers who accept the training related to MSM-specific healthcare.

Outcome measures

Outcome data not reported

Adverse Events

Recipients of HIV Prevention Services

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Recipients of HIV Prevention Services n=100 participants at risk Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV Testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
Hepatobiliary disorders Elevated liver enzymes, secondary to Hepatitis C diagnosis	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Hepatobiliary disorders Elevated liver enzymes	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.

Other adverse events

Measure	Recipients of HIV Prevention Services n=100 participants at risk Study participants receiving a comprehensive package of HIV prevention services including: condom choices, condom-compatible lubricant choices, couples HIV counseling and testing (CVCT), staff and provider MSM and LGBT sensitization training, HIV Testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.
General disorders Fatigue, possibly or probably related to PrEP	4.0% 4/100 • Number of events 4 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Gastrointestinal disorders Gastrointestinal symptoms, possibly or probably related to PrEP	7.0% 7/100 • Number of events 8 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Thirst, possibly or probably related to PrEP	2.0% 2/100 • Number of events 2 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Sweating, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Hypersomnia, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Immune system disorders Hypersensitivity reaction, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Metabolism and nutrition disorders Symptoms of hyperglycemia, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Vascular disorders Hypertension, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Polydypsia, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Skin and subcutaneous tissue disorders Generalized pruritis, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Glycosuria, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Immune system disorders Hypersensitivity reaction, possibly or probably related to Hepatitis B vaccination	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Gastrointestinal disorders Gastrointestinal symptoms, possibly or probably related to sexually transmitted infection treatment	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
Social circumstances Social harm: participant's family member found their PrEP study medication	3.0% 3/100 • Number of events 3 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.
General disorders Dry mouth, possibly or probably related to PrEP	1.0% 1/100 • Number of events 1 • Adverse events were collected during the entire 12 month study period. All symptoms reported as possibly or probably related to a study intervention are reported as adverse events. In this study, the interventions include the HIV prevention interventions (condoms, lubricant, CVCT, PrEP) and community interventions. Possible adverse events include social harms such as stigma and discrimination in health care settings, verbal abuse, relationship disruption, and loss of access to services.

Additional Information

Patrick S Sullivan PhD/DVM

Emory University

Phone: 404-727-2038

Email: pssulli@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place