Couples in Context: An RCT of a Couples-based HIV Prevention Intervention

NCT01953133 | Unknown DMC

• 1 other identifier: MH086346
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence for human immunodeficiency virus (HIV) in South Africa is 18% among 15-49 year old adults and 30% among female antenatal clinic attendees (UNAIDS, 2007), indicating continuing need for effective HIV prevention. Further, recent studies in sub-Saharan Africa found 60-94% of new HIV infections are occurring within marriage or co-habiting heterosexual partnerships (Dunkle et al., 2008). These findings signal the need for HIV prevention interventions that target couples in South Africa. This study is a randomized controlled trial of a behavioral intervention to increase HIV testing among couples living in Vulindlela, South Africa. The proposed intervention consists of six sessions (one mixed gender group, one single gender group, and four couples' counseling sessions). Using a randomized controlled trial (RCT) design with 350 heterosexual couples, we will test the hypothesis that compared with a one-time mixed-gender group session, the proposed intervention will improve communication, intimacy and trust necessary for mutual decision-making about behaviours related to sexual risk behaviour and testing for HIV. Improving couples' ability and motivation to participate in Couples HIV Testing and Counseling (CHTC) for HIV will in turn lead to reductions in sexual risk behaviour. Both of these outcomes are necessary and effective strategies to reduce the risk of HIV transmission within primary partnerships. This intervention is informed by several qualitative studies conducted in Vulindlela and Soweto, South Africa via a K08 award from NIH, as well as other funding sources. These preliminary studies provided insight into the challenges couples face in participating in CHCT, as well as the skills they need in order to address these barriers. Our experience conducting both qualitative and quantitative studies with comparable populations (i.e. South African couples) has also informed the recruitment and retention methods in this intervention. The proposed study takes advantage of the infrastructure and collaborative relationships that the PI has developed that have enabled her to implement and conduct research within these communities. The specific aims of the project are to test the efficacy of a theory-based and culturally appropriate couples-based intervention on the following outcomes:

1. 1.Rates of testing for HIV,
2. 2.Sexual risk behaviour for HIV (with primary and any concurrent partners).

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Rates of testing for HIV

  Measuring whether participants underwent Couples HIV Counseling and Testing (CHCT) through the study.

  Up to 9 Months post intervention

• Sexual Risk Behavior

  Measuring specific sexual risk behaviors including condom use and concurrent partnerships.

  Up to 9 months post intervention

Secondary Outcomes (1)

• Mediating Factors

  9 Month Follow Up

Study Arms (2)

Control

NO INTERVENTION

Couples do not receive intervention (counseling sessions) during study period. They do undergo one group-based session. Upon completion of 9 month follow-up, participants in this arm can undergo a condensed, 2 session version of the intervention.

Couples' Counseling Sessions

EXPERIMENTAL

4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.)

Behavioral: Couples Counselling Sessions

Interventions

Couples Counselling Sessions BEHAVIORAL

4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.)

Couples' Counseling Sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both partners 18 or older
• in a relationship with opposite sex partner (defined as: "are you currently in a relationship with a person of the opposite sex to whom you feel committed above anyone else and with whom you have had sexual relations?")
• Both partners report the relationship length has lasted at least 6 months
• Both partners willing and able to provide informed consent

You may not qualify if:

• Both partners report participating in couples-based testing for HIV with their current partner (Defined as: Both partners tested for HIV at the same time and disclosed results).
• Either partner reports current marital status as polygamous
• Either partner reports domestic violence (as actor or recipient) within the past 6 months with the current partner.
• Both partners have ever disclosed HIV test results to each other via individual or couples testing

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Human Sciences Research Council Sweetwaters

Vilundlela, KwaZulu-Natal, South Africa

Location

Related Publications (2)

• Dunkle KL, Stephenson R, Karita E, Chomba E, Kayitenkore K, Vwalika C, Greenberg L, Allen S. New heterosexually transmitted HIV infections in married or cohabiting couples in urban Zambia and Rwanda: an analysis of survey and clinical data. Lancet. 2008 Jun 28;371(9631):2183-91. doi: 10.1016/S0140-6736(08)60953-8.

  PMID: 18586173 BACKGROUND

• Darbes LA, van Rooyen H, Hosegood V, Ngubane T, Johnson MO, Fritz K, McGrath N. Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa. Trials. 2014 Feb 20;15:64. doi: 10.1186/1745-6215-15-64.

  PMID: 24552199 BACKGROUND

Study Officials

• Lynae Darbes, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 30, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

ZA (1)