Demand Creation for Couples' HIV Counseling and Testing

NCT02492061 | Unknown

• 1 other identifier: 2011/HD07/18256U
• Study Type: interventional
• Target: 3,076
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims at assessing the effect of a demand-creation intervention on couples' HIV counseling and testing (couples' HCT) uptake among married couples who have never tested together as a couple. The study is being implemented in 12 clusters; six intervention and six comparison clusters. A total of 1,538 couples will be enrolled into the study; 769 couples per arm. Couples in the intervention communities are invited to participate in small group, couple-focused or men-only, interactive sessions lasting 3-4 hours in which the advantages and fears associated with couples' HCT are discussed with invited couples to motivate them to consider testing together as a couple. The meetings are reinforced with testimonies from previously tested couples. At the end of the sessions, couples or men receive invitation coupons which they present to a designated health facility to receive couples' HCT services (couples are free to receive individual HCT or not to honor the invitation, if they are not interested in taking the HCT offer). In the comparison communities, standard of care health education activities including general adult community sessions are held but couples do not receive any invitations to test as a couple. Nevertheless, couples in the comparison communities have unlimited access to HIV counseling and testing services that are offered by the Rakai Health Sciences Program within the study communities. The investigators hypothesize that couples in the intervention arm will be more likely to test together than those in the comparison arm. The study objectives include: a) exploring the motivations for and barriers to couples' HCT uptake; b) assessing the effect of a demand-creation intervention on couples' HCT uptake among married couples with no prior couples' HCT experience, and c) exploring the effect of couples' HCT vs. individual HCT on linkage to and retention in HIV care.

Conditions

HIV/AIDS

Keywords

couples' HCT married couples; Rakai; Uganda

Outcome Measures

Primary Outcomes (1)

• Proportion of married individuals who have received couples' HCT

  Overall proportion of married individuals that will have received couples' HCT (out of those who have never received couples' HCT) as a result of the intervention. We will compare the proportion of married individuals receiving couples' HCT in the intervention arm to the proportion receiving couples' HCT in the comparison arm. The intervention will be considered to have been successful if the proportion of married individuals who received couples' HCT is 10% higher in the intervention than in the comparison arm.

  3 months after end of intervention

Secondary Outcomes (2)

• Proportion of HIV-positive individuals who have been enrolled in HIV care

  6 months after end of intervention

• Proportion of enrolled HIV-positive individuals who have been retained in HIV care

  9 months after end of intervention

Study Arms (2)

Demand creation

ACTIVE COMPARATOR

In the intervention arm, demand creation for couples' HCT is done using small group (comprising about 20 people), couple-focused or men-only, interactive sessions. A senior counselor facilitates the sessions in which the advantages and fears associated with couples' HCT are discussed with invited couples or men. The sessions are reinforced by testimonies from couples or men who have ever tested as a couple. Attending couples or men receive couple invitation coupons inviting them to test for HIV together with their partners at a designated health facility in the community.

Behavioral: Demand creation for couples' HCT

Standard of care

NO INTERVENTION

In the standard of care arm, participants receive general adult health talks to educate them about the importance of HIV testing (including couples' HCT) but no invitations are issued to invite couples to test for HIV together with their partners at a designated health facility. However, couples can seek HCT out of their own volition. The sessions are not stratified by marital status, and attendants include all those who are willing and are able to attend.

Interventions

Demand creation for couples' HCT BEHAVIORAL

The demand creation for couples' HCT intervention aims at improving uptake of couples' HCT among married couples in Rakai, southwestern Uganda

Demand creation

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Currently married individuals
• Marital duration of \>=1 year
• No previous HIV testing or previous individual HIV testing
• If HIV-positive, not yet enrolled in HIV care

You may not qualify if:

• Not currently married
• Marital duration \< 1 year
• Previous receipt of couples' HIV counseling and testing
• Previous self-reported joint HIV status disclosure

Sponsors & Collaborators

• Makerere University: lead
• Rakai Health Sciences Program: collaborator

Related Publications (4)

• Grabowski MK, Lessler J, Redd AD, Kagaayi J, Laeyendecker O, Ndyanabo A, Nelson MI, Cummings DA, Bwanika JB, Mueller AC, Reynolds SJ, Munshaw S, Ray SC, Lutalo T, Manucci J, Tobian AA, Chang LW, Beyrer C, Jennings JM, Nalugoda F, Serwadda D, Wawer MJ, Quinn TC, Gray RH; Rakai Health Sciences Program. The role of viral introductions in sustaining community-based HIV epidemics in rural Uganda: evidence from spatial clustering, phylogenetics, and egocentric transmission models. PLoS Med. 2014 Mar 4;11(3):e1001610. doi: 10.1371/journal.pmed.1001610. eCollection 2014 Mar.

  PMID: 24595023 BACKGROUND

• Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.

  PMID: 17321311 BACKGROUND

• Todd J, Carpenter L, Li X, Nakiyingi J, Gray R, Hayes R. The effects of alternative study designs on the power of community randomized trials: evidence from three studies of human immunodeficiency virus prevention in East Africa. Int J Epidemiol. 2003 Oct;32(5):755-62. doi: 10.1093/ije/dyg150.

  PMID: 14559745 BACKGROUND

• Matovu JK, Todd J, Wanyenze RK, Kairania R, Serwadda D, Wabwire-Mangen F. Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial. BMC Infect Dis. 2016 Aug 8;16:379. doi: 10.1186/s12879-016-1720-y.

  PMID: 27502776 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Joseph KB Matovu, MHS

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07