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Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women

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ClinicalTrials.gov Identifier: NCT00362375
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : May 14, 2010
Last Update Posted : May 14, 2010
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Infections
Interventions: Behavioral: Healthy Love Workshop
Behavioral: HIV/AIDS 101 Workshop

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Information about the study was disseminated through print media, public service announcements on local radio stations, electronic communication and informational mailings to local AIDS service organizations, county health departments, medical clinics, and community centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
28 groups did not participate for logistical reasons, including lack of follow-up by group contact (10 groups), failure of women to arrive for the workshop (7 groups), and too few women to meet minimum workshop size (6 groups). Five groups did not participate because of insufficient interest by their members in receiving either workshop.

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Participant Flow:   Overall Study
    Healthy Love Workshop   HIV101
STARTED   161 [1]   152 [1] 
COMPLETED   121 [2]   117 [2] 
NOT COMPLETED   40   35 
Lost to Follow-up                40                35 
[1] Number eligible and randomized
[2] Number completed 6-month follow-up assessment



  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.
No text entered.

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
Total Total of all reporting groups

Baseline Measures
   Healthy Love Workshop   HIV101   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 161   152   313 
Age 
[Units: Years]
Mean (Standard Deviation) 		 29.1  (10.1)   33.7  (12.7)   31.3  (11.6) 
Gender 
[Units: Participants]
 		     
Female   161   152   313 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
 		     
United States   161   152   313 


  Outcome Measures

1.  Primary:   Condom Use During Vaginal Sex With Any Male Partner   [ Time Frame: Past 3 months ]

Measure Type Primary
Measure Title Condom Use During Vaginal Sex With Any Male Partner
Measure Description Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
Time Frame Past 3 months  

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.
Women who were sexually active at 3-month follow-up and who provided data on outcome measure

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Measured Values
   Healthy Love Workshop   HIV101 
Participants Analyzed 
[Units: Participants]
 		 93   94 
Condom Use During Vaginal Sex With Any Male Partner 
[Units: Percent]
 		 59.3   39.6 


Statistical Analysis 1 for Condom Use During Vaginal Sex With Any Male Partner
Groups [1] HIV101
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Generalized Estimating Equation
P Value [4] <0.05
Odds Ratio (OR) [5] 2.40
95% Confidence Interval 1.28 to 4.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  GEE cluster-adjusted odds ratio
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   HIV Testing and Receipt of Results   [ Time Frame: Past 3 months ]

Measure Type Secondary
Measure Title HIV Testing and Receipt of Results
Measure Description Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
Time Frame Past 3 months  

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.
Based on the number of women who provided data at the 3-month follow-up

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Measured Values
   Healthy Love Workshop   HIV101 
Participants Analyzed 
[Units: Participants]
 		 116   116 
HIV Testing and Receipt of Results 
[Units: Percent]
 		 20.2   16.3 


Statistical Analysis 1 for HIV Testing and Receipt of Results
Groups [1] HIV101
Statistical Test Type [2] Superiority or Other
Statistical Method [3] GEE
P Value [4] <0.05
Odds Ratio (OR) [5] 1.44
95% Confidence Interval 0.76 to 2.71
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Other Pre-specified:   Sexual Abstinence   [ Time Frame: Past 3 months ]

Measure Type Other Pre-specified
Measure Title Sexual Abstinence
Measure Description The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Time Frame Past 3 months  

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.
Based on the number of women who provided valid data at the 3-month follow-up

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Measured Values
   Healthy Love Workshop   HIV101 
Participants Analyzed 
[Units: Participants]
 		 93   94 
Sexual Abstinence 
[Units: Percent]
 		 36.6   43.6 


Statistical Analysis 1 for Sexual Abstinence
Groups [1] HIV101
Statistical Test Type [2] Superiority or Other
Statistical Method [3] GEE
P Value [4] <0.05
Odds Ratio (OR) [5] 0.48
95% Confidence Interval 0.20 to 1.16
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Other Pre-specified:   Unprotected Vaginal Sex With Any Male Partner   [ Time Frame: Past 3 months ]

Measure Type Other Pre-specified
Measure Title Unprotected Vaginal Sex With Any Male Partner
Measure Description The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months
Time Frame Past 3 months  

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.
Based on the number of women who provided valid data at the 3-month follow-up

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Measured Values
   Healthy Love Workshop   HIV101 
Participants Analyzed 
[Units: Participants]
 		 93   94 
Unprotected Vaginal Sex With Any Male Partner 
[Units: Percent]
 		 37.6   36.2 


Statistical Analysis 1 for Unprotected Vaginal Sex With Any Male Partner
Groups [1] HIV101
Statistical Test Type [2] Superiority or Other
Statistical Method [3] GEE
P Value [4] <0.05
Odds Ratio (OR) [5] 1.39
95% Confidence Interval 0.99 to 1.95
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Other Pre-specified:   Number of Male Sex Partners   [ Time Frame: Past 3 months ]

Measure Type Other Pre-specified
Measure Title Number of Male Sex Partners
Measure Description The number of male sex partners during the past 3 months
Time Frame Past 3 months  

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.
Based on the number of women who provided valid data at the 3-month follow-up

Reporting Groups
  Description
Healthy Love Workshop The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
HIV101 The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.

Measured Values
   Healthy Love Workshop   HIV101 
Participants Analyzed 
[Units: Participants]
 		 93   94 
Number of Male Sex Partners 
[Units: Number of sex partners]
Mean (Standard Deviation) 		 0.70  (0.60)   0.67  (0.74) 


Statistical Analysis 1 for Number of Male Sex Partners
Groups [1] HIV101
Statistical Test Type [2] Superiority or Other
Statistical Method [3] GEE
P Value [4] <0.05
Odds Ratio (OR) [5] 1.07
95% Confidence Interval 0.80 to 1.44
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  GEE incident rate ratio
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



6.  Secondary:   HIV Knowledge   [ Time Frame: current ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Condom Use Self-efficacy   [ Time Frame: current ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Knowledge of HIV Test   [ Time Frame: current ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information