HIV/AIDS Clinical Trial
Official title:
Demand Creation for Couples' HIV Counseling and Testing, Linkage to and Retention in HIV Care Among Married Couples in Rakai, Uganda
Verified date | July 2015 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: Research Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 3076 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years to 49 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Not currently married - Marital duration < 1 year - Previous receipt of couples' HIV counseling and testing - Previous self-reported joint HIV status disclosure |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Makerere University | Rakai Health Sciences Program |
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Proportion of HIV-positive individuals who have been enrolled in HIV care | Proportion of HIV-positive individuals (who were not yet in HIV care) who have been enrolled in HIV care at 1, 3 and 6 months after the intervention. We will assess differences in enrollment in HIV care between those who received couples' HCT and those who received individual HCT to determine the relative effect of couples' HCT over individual HCT in improving linkage to HIV care. | 6 months after end of intervention | No |
Secondary | Proportion of enrolled HIV-positive individuals who have been retained in HIV care | Proportion of enrolled HIV-positive individuals who are still in HIV care at 3, 6, and 9 months after enrollment. We will assess differences in retention in HIV care between those who previously received couples' HCT (prior to enrollment) and those who previously received individual HCT to determine the relative effect of couples' HCT over individual HCT in improving retention in HIV care. | 9 months after end of intervention | No |
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