Condition category
Infections and Infestations
Date applied
12/01/2017
Date assigned
25/01/2017
Last edited
01/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gender norms (roles men and women are usually expected to fulfill in society) can be harmful to a woman’s health. Unfair and unequal gender expectations can lead to gender based violence (GBV), putting women at risk of being infected with human immunodeficiency virus (HIV). Community response (CR) programs (programs developed to make community level changes) seek to change harmful gender norms and improve health behaviors. Combining HIV testing centers with other health intervention and education programs can help improve access to healthcare as well as reduce HIV infections. Areas with high rates of HIV and GBV in South Africa have implemented CR programs in order to combine education about gender violence with HIV prevention. The aim of this study is to assess a CR program in order to see how well it works at preventing HIV, reducing gender based violence risks and improving the overall health of the community.

Who can participate?
Adults living in the communities where the CR program is taking place who are able to read in English or in the local language.

What does the study involve?
Participants are randomly selected from the areas that receive the CR program. The CR program aims to prevent HIV and sexual and gender-based violence, and includes the Stepping Stones curriculum, community engagement, and awareness-raising around GBV and HIV. Participants fill out four surveys regarding the CR program, one at the beginning of the program and then a further three times at ten month intervals. These surveys assess the knowledge they have gained about HIV, healthcare services, gender norms and sexual based violence in order to see how well the CR program is working.

What are the possible benefits and risks of participating?
There are no direct benefits to participants, but the program can help prevent HIV and GBV. The main risks of participation are possible breaches of participant confidentiality, as well as exposure to sensitive questions about sex, HIV and other STIs, and GBV during the study interviews. As a result, some of the participants may become uncomfortable or upset.

Where is the study run from?
The study is run from the Population Council (USA) and MatCH Research Unit at the University of the Witwaterstrand (South Africa) and takes place in informal settlements in eThekwini and Ugu in KwaZulu-Natal Province (South Africa)

When is the study starting and how long is it expected to run for?
September 2015 to August 2019

Who is funding the study?
United States Agency for International Development (USA)

Who is the main contact?
Stephanie Psaki

Trial website

http://www.popcouncil.org/research/supporting-operational-aids-research-project-soar

Contact information

Type

Scientific

Primary contact

Dr Stephanie Psaki

ORCID ID

http://orcid.org/0000-0002-0332-7653

Contact details

Population Council
One Dag Hammarskjold Plaza
New York
10017
United States of America

Type

Scientific

Additional contact

Dr Julie Pulerwitz

ORCID ID

Contact details

Population Council
4301 Connecticut Avenue NW
Suite 280
Washington
DC
20008
United States of America

Type

Scientific

Additional contact

Dr Paul Hewett

ORCID ID

Contact details

Population Council
4301 Connecticut Avenue NW
Suite 280
Washington
DC
20008
United States of America

Type

Scientific

Additional contact

Dr Mags Beksinska

ORCID ID

Contact details

MatCH Research Unit
University of Witwatersrand
34 Essex Terrace
2nd Bldg
Ground Floor
Westville
Durban
3692
South Africa

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PC741

Study information

Scientific title

Evaluation of the PEPFAR/USAID Community Responses program among adults in informal settlements in KwaZulu-Natal, South Africa

Acronym

Study hypothesis

The primary goal of the proposed Community Responses (CR) program evaluation is to determine the extent to which the United States Agency for International Development (USAID)/South Africa-funded CR program (and particularly the effects of community-based HIV/gender-based violence (GBV) prevention programming, which include a component to create demand for related services) is effective at reducing HIV and sexual and GBV risk, and improving related service utilization.

Ethics approval

1. Population Council Institutional Review Board, 05/10/2016, ref: protocol #741
2. The Human Research Ethics Committee (HREC), University of Witwatersrand, 11/01/2017, ref: R14/49

Study design

Multi-centre longitudinal cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

HIV/AIDS, Sexual and gender-based violence (SGBV)

Intervention

All participants are living in communities where the Community Responses program will take place during follow-up, although the timing of program start-up has been randomly staggered. The program, implemented by CCI in South Africa, includes several overlapping components:
1. Standardized HIV prevention interventions
2. Structural interventions for gender norms for HIV and GBV prevention
3. SGBV prevention activities
4. Community dialogues

Adult men and women living in intervention (Community Responses program) communities where the intervention are randomly selected and surveyed at approximate 10 month intervals (baseline, 10, 20 and 30 months). Information will be collected on the following topics: demographic and household socio-economic status, HIV knowledge and use of services, sexual behaviour, gender norms and sexual relationship power, and experience and perpetration of gender-based violence. This information will be used to determine whether the intervention (Community Responses program) is effective in achieving the key outcomes of interest, and to understand any variations in effects between groups.

Routine program monitoring data collected by the organization implementing the intervention is also collected in order to assess the level of exposure to the program within each community.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Percentage of participants who have obtained the results of an HIV test within the previous six months is assessed using self-reported data from a questionnaire administered at baseline and three follow-up rounds, with 10 months between each round
2. Percentage of HIV-positive participants who have accessed HIV care and treatment services within the previous six months is assessed using self-report data from a questionnaire administered at baseline and three follow-up rounds, with 10 months between each round
3. Percentage of participants reporting using a condom at last sex is measured using the self reported data from a questionnaire administered at baseline and three follow-up rounds, with 10 months between each round
4. Percentage of participants reporting consistent condom use with a partner of unknown HIV status in the last six months measured using the self reported data from a questionnaire administered at baseline and three follow up rounds, with 10 months between each round
5. Percentage of participants reporting perpetrating or experiencing physical violence within the previous six months is measured using the self reported data from a questionnaire administered at baseline and three follow up rounds, with 10 months between each round
6. Percentage of participants reporting perpetrating or experiencing sexual violence within the previous six months is measured using the self reported data from a questionnaire administered at baseline and three follow up rounds, with 10 months between each round
7. Percentage of participants who hold positive norms regarding gender based violence is measured using the Gender-Equitable Men (GEM) Scale at baseline and three follow up rounds, with 10 months between each round
8. Percentage of participants who hold equitable norms regarding the roles of women and men is measured using the Gender-Equitable Men (GEM) Scale at baseline and three follow up rounds, with 10 months between each round

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2015

Overall trial end date

14/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men aged 18-35
2. Women aged 18-24
3. Living in selected communities
4. Can read English or local language
5. Willing and able to give informed consent
6. Willing to participate in three additional interviews
7. Willing to provide research staff with an identity number, address, phone number, and fingerprint scan while participating in the study
8. Agrees to participate in the study for the duration of up to three years; do not reasonably foresee moving out of the study area within that time

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

20 pretest participants 1500 final survey participants

Participant exclusion criteria

1. Lives outside of study area or expects to move within next 3 years
2. Outside of age range
3. Cannot read in English or local language

Recruitment start date

23/01/2017

Recruitment end date

15/03/2017

Locations

Countries of recruitment

South Africa

Trial participating centre

Population Council
One Dag Hammarskjold Plaza
New York
10017
United States of America

Trial participating centre

University of the Witwaterstrand
MatCH Research Unit 34 Essex Terrace 2nd Bldg, Ground Floor Westville, 3629 Durban, South Africa
Durban
3629
South Africa

Sponsor information

Organisation

Population Council

Sponsor details

One Dag Hammarskjold Plaza
New York
NY
10017
United States of America

Sponsor type

Government

Website

www.popcouncil.org

Funders

Funder type

Not defined

Funder name

United States Agency for International Development

Alternative name(s)

U.S. Agency for International Development, USAID

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

A Research Advisory Group (RAG) has been established to provide input into the study design, implementation, and dissemination of findings throughout the study. This group includes representatives from the donor (USAID), the research community, and the local and national government.

Information generated from the study will be shared with the research communities through well-established relationships with Wits University and other academic institutions in South Africa and internationally. Findings will also be disseminated to key stakeholders in KwaZulu-Natal Province, including the Department of Health, as well as nationally.

IPD Sharing plan:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/08/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes