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

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00362375
• Collaborator: SisterLove, Inc. (Other)
• Enrollment: 313
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 13.6

Study Details

Study Description

Brief Summary

The purpose of this program evaluation is to determine whether the Health Love Workshop, a group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American women and women of African descent. The intent of this program is to support an evaluation of the efficacy of the intervention and to provide feedback to the implementing organization to increase intervention effectiveness.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Sexually Transmitted Infections	Behavioral: Healthy Love Workshop; Behavioral: HIV/AIDS 101 Workshop	Phase 1/Phase 2

Detailed Description

SisterLove, Inc. in Atlanta, Georgia, is evaluating its HIV/AIDS prevention intervention called the Healthy Love Workshop (HLW). The HLW targets African American women and women of African descent who are at risk for HIV infection and transmission. The HLW, which lasts 3 to 4 hours and is delivered during a single session, is a highly interactive workshop that aims to provide a safe environment in which women can learn about: a) the modes of HIV transmission, b) effective strategies for reducing one's risk for contracting or transmitting HIV or other STIs, c) opportunities to develop or enhance skills for self-assessing the risk level of sexual behaviors and the use of safer sex techniques, and d) how to develop an awareness of personal, community and social attitudes, beliefs and norms that influence women's relationships, sexual behavior, and decision-making. SisterLove will identify a minimum of 28 groups of women to participate in the evaluation, which will use a concurrent comparison design with block randomization. These groups will be typical of those that currently receive the HLW, including but not limited to sororities, friendship circles, church groups and other affinity-based groups. Fourteen of the 28 groups will participate in HLW as the intervention group; 14 of the recruited groups will participate in an HIV/AIDS 101 workshop (HIV 101) as the comparison group. Each group will contain about 15 women, thus approximately 420 women will participate in the evaluation. Outcome measures will assess HIV/AIDS knowledge, attitudes towards condom use and HIV testing, condom use intentions, personal HIV/AIDS risk assessment, self-efficacy for taking steps to prevent HIV transmission, consistent condom use, sexual abstinence, and reduction in other sexual risk behaviors. These outcomes will be measured at baseline, and after the intervention at 3- and 6-month follow-ups.

Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 313 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Love Workshop Single-session, small-group HIV prevention intervention	Behavioral: 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.; Other Names: Healthy Love Party Healthy Love
Active Comparator: HIV101 Single-session, small-group intervention providing facts regarding HIV/AIDS	Behavioral: HIV/AIDS 101 Workshop; The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW. The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing. However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW.; Other Names: HIV101

Outcome Measures

Primary Outcome Measures

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

   Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months

Secondary Outcome Measures

1. HIV Testing and Receipt of Results [Past 3 months]

   Percentage of women who reported testing for HIV infection and received their test results during the past 3 months

2. HIV Knowledge [current]

3. Condom Use Self-efficacy [current]

4. Knowledge of HIV Test [current]

Other Outcome Measures

1. Sexual Abstinence [Past 3 months]

   The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners

2. Unprotected Vaginal Sex With Any Male Partner [Past 3 months]

   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

3. Number of Male Sex Partners [Past 3 months]

   The number of male sex partners during the past 3 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women of African descent (including African Americans, Caribbean, and African Immigrants)

• Over the age of 18 years

Exclusion Criteria:

• Women who are pregnant or planning to become pregnant

• Do not speak English

• Recent (past 6 months) participation in HIV prevention workshop

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SisterLove, Inc.	Atlanta	Georgia	United States	30331

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• SisterLove, Inc.

Investigators

• Principal Investigator: Dazon Dixon Diallo, MPH, President/CEO SisterLove, Inc.
• Study Director: Jeffrey H Herbst, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
• Study Director: Thomas M Painter, PhD, Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• SisterLove, Inc.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00362375
• Other Study ID Numbers: CDC-NCHSTP-1927-4768; U65/CCU424514-02
• First Posted: Aug 10, 2006
• Last Update Posted: May 14, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Adult; *HIV Infections/pc [Prevention & Control]; Female; Humans; Risk-Taking; Safe Sex; Sexual Behavior; HIV Testing
• Additional relevant MeSH terms: Infections; Communicable Diseases; HIV Infections; Sexually Transmitted Diseases

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	161	152
COMPLETED	121	117
NOT COMPLETED	40	35

Baseline Characteristics

Arm/Group Title	Healthy Love Workshop	HIV101	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	161	152	313
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (10.1)	33.7 (12.7)	31.3 (11.6)
Sex: Female, Male (Count of Participants)
Female	161 100%	152 100%	313 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	161 100%	152 100%	313 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Measure Participants	93	94
Number [Percent]	59.3	39.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV101
	Comments	GEE cluster-adjusted odds ratio
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Generalized Estimating Equation
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.40
	Confidence Interval	(2-Sided) 95%; 1.28 to 4.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Measure Participants	93	94
Number [Percent]	36.6	43.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV101
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; 0.20 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Unprotected Vaginal Sex With Any Male Partner
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Measure Participants	93	94
Number [Percent]	37.6	36.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV101
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Other Pre-specified Outcome

Title	Number of Male Sex Partners
Description	The number of male sex partners during the past 3 months
Time Frame	Past 3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Measure Participants	93	94
Mean (Standard Deviation) [Number of sex partners]	0.70 (0.60)	0.67 (0.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV101
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	GEE
	Comments	GEE incident rate ratio
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	HIV Testing and Receipt of Results
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Healthy Love Workshop	HIV101
Arm/Group Description	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.	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.
Measure Participants	116	116
Number [Percent]	20.2	16.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HIV101
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95%; 0.76 to 2.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	HIV Knowledge
Time Frame	current

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Condom Use Self-efficacy
Time Frame	current

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Knowledge of HIV Test
Time Frame	current

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Healthy Love Workshop		HIV101
Arm/Group Description	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.		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.
All Cause Mortality
	Healthy Love Workshop		HIV101
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Healthy Love Workshop		HIV101
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/161 (0%)		0/152 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Love Workshop		HIV101
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/161 (0%)		0/152 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.