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

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ClinicalTrials.gov Identifier: NCT02043015
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV
Interventions: Behavioral: Condom choices
Behavioral: Condom-compatible lubricant choices
Behavioral: Couples HIV counseling and testing (CVCT)
Drug: Pre-exposure prophylaxis with FTC/TDF
Other: Staff and provider MSM and LGBT sensitization training
Behavioral: HIV Testing and Risk-reduction counseling
Behavioral: Linkage to care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in Cape Town, South Africa between February 2015 and September 2015. Each participant was followed for one year.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Recipients of HIV Prevention Services
STARTED   115 
COMPLETED   87 
NOT COMPLETED   28 
Lost to Follow-up                4 
Withdrawal by Subject                4 
Removed once target enrollment reached                15 
Participant moved away from study city                4 
Incarceration                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Baseline analysis population consists of persons who consented to take part in the study and were eligible to participate.

Reporting Groups
  Description
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), staff and provider MSM and LGBT sensitization training, HIV testing, risk-reduction counseling, linkage to care, and pre-exposure prophylaxis with FTC/TDF.

Baseline Measures
   Recipients of HIV Prevention Services 
Overall Participants Analyzed 
[Units: Participants]
 115 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      115 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.3  (7.4) 
Sex/Gender, Customized [1] 
[Units: Participants]
Count of Participants
 
Gender identification   
Female      7   6.1% 
Male      99  86.1% 
Transgender      5   4.3% 
Other      1   0.9% 
Unknown or not reported      3   2.6% 
[1] Eligible participants were male at birth. As part of demographic assessments, all participants were asked to self-identify their gender as Male, Female, Transgender, or Other.
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
 
Black African      89  77.4% 
Coloured      21  18.3% 
White      4   3.5% 
Unknown or not reported      1   0.9% 
[1] As part of demographic assessments, all participants were asked to self-identify their race as Black African, Coloured (a multiracial ethnic group in South Africa), Indian or Asian, White, or Other.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
South Africa   115 
HIV Status at Baseline Visit 
[Units: Participants]
Count of Participants
 
HIV-Positive at Baseline      35  30.4% 
HIV-Negative at Baseline      80  69.6% 


  Outcome Measures

1.  Primary:   Retention in the Cohort   [ Time Frame: 12 months ]

2.  Primary:   Use of PrEP   [ Time Frame: 4 months ]

3.  Primary:   Number of Participants With New HIV Infection   [ Time Frame: 12 months ]

4.  Secondary:   Condom Use   [ Time Frame: Months 3, 6, and 12 ]

5.  Secondary:   Lubricant Use   [ Time Frame: Months 3, 6, and 12 ]

6.  Secondary:   Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake   [ Time Frame: 12 months ]

7.  Secondary:   Number of HIV Tests During Study   [ Time Frame: 12 months ]

8.  Secondary:   Serodiscordant Unprotected Anal Intercourse (UAI)   [ Time Frame: Month 3, 6, and 12 ]

9.  Secondary:   Acceptability of Post-exposure Prophylaxis (PEP)   [ Time Frame: 12 months ]

10.  Secondary:   Acceptability of Provider Training   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Patrick S Sullivan PhD/DVM
Organization: Emory University
phone: 404-727-2038
e-mail: pssulli@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Patrick S Sullivan, Emory University
ClinicalTrials.gov Identifier: NCT02043015     History of Changes
Other Study ID Numbers: IRB00054863
MP3-1R01A1094575 ( Other Identifier: Other )
First Submitted: January 21, 2014
First Posted: January 23, 2014
Results First Submitted: October 19, 2017
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018