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

Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00362375
Enrollment
313
Registered
2006-08-10
Start date
2006-05-31
Completion date
2008-04-30
Last updated
2010-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Infections

Keywords

Adult, *HIV Infections/pc [Prevention & Control], Female, Humans, Risk-Taking, Safe Sex, Sexual Behavior, HIV Testing

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.

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.

Interventions

BEHAVIORALHealthy 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.

BEHAVIORALHIV/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.

Sponsors

SisterLove, Inc.
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Condom Use During Vaginal Sex With Any Male PartnerPast 3 monthsPercentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months

Secondary

MeasureTime frameDescription
Condom Use Self-efficacycurrent
Knowledge of HIV Testcurrent
HIV Knowledgecurrent
HIV Testing and Receipt of ResultsPast 3 monthsPercentage of women who reported testing for HIV infection and received their test results during the past 3 months

Other

MeasureTime frameDescription
Number of Male Sex PartnersPast 3 monthsThe number of male sex partners during the past 3 months
Sexual AbstinencePast 3 monthsThe percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners
Unprotected Vaginal Sex With Any Male PartnerPast 3 monthsThe 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

Countries

United States

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 details

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.

Participants by arm

ArmCount
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.
161
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.
152
Total313

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up4035

Baseline characteristics

CharacteristicHealthy Love WorkshopHIV101Total
Age Continuous29.1 years
STANDARD_DEVIATION 10.1
33.7 years
STANDARD_DEVIATION 12.7
31.3 years
STANDARD_DEVIATION 11.6
Region of Enrollment
United States
161 participants152 participants313 participants
Sex: Female, Male
Female
161 Participants152 Participants313 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1610 / 152
serious
Total, serious adverse events
0 / 1610 / 152

Outcome results

Primary

Condom Use During Vaginal Sex With Any Male Partner

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

Time frame: Past 3 months

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

ArmMeasureValue (NUMBER)
Healthy Love WorkshopCondom Use During Vaginal Sex With Any Male Partner59.3 Percent
HIV101Condom Use During Vaginal Sex With Any Male Partner39.6 Percent
Comparison: GEE cluster-adjusted odds ratiop-value: <0.0595% CI: [1.28, 4.5]Generalized Estimating Equation
Secondary

Condom Use Self-efficacy

Time frame: current

Secondary

HIV Knowledge

Time frame: current

Secondary

HIV Testing and Receipt of Results

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

ArmMeasureValue (NUMBER)
Healthy Love WorkshopHIV Testing and Receipt of Results20.2 Percent
HIV101HIV Testing and Receipt of Results16.3 Percent
p-value: <0.0595% CI: [0.76, 2.71]GEE
Secondary

Knowledge of HIV Test

Time frame: current

Other Pre-specified

Number of Male Sex Partners

The number of male sex partners during the past 3 months

Time frame: Past 3 months

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

ArmMeasureValue (MEAN)Dispersion
Healthy Love WorkshopNumber of Male Sex Partners0.70 Number of sex partnersStandard Deviation 0.6
HIV101Number of Male Sex Partners0.67 Number of sex partnersStandard Deviation 0.74
p-value: <0.0595% CI: [0.8, 1.44]GEE
Other Pre-specified

Sexual Abstinence

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

Time frame: Past 3 months

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

ArmMeasureValue (NUMBER)
Healthy Love WorkshopSexual Abstinence36.6 Percent
HIV101Sexual Abstinence43.6 Percent
p-value: <0.0595% CI: [0.2, 1.16]GEE
Other Pre-specified

Unprotected Vaginal Sex With Any Male Partner

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

ArmMeasureValue (NUMBER)
Healthy Love WorkshopUnprotected Vaginal Sex With Any Male Partner37.6 Percent
HIV101Unprotected Vaginal Sex With Any Male Partner36.2 Percent
p-value: <0.0595% CI: [0.99, 1.95]GEE

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026