Background. Selective study participation and retention in clinical trials raise questions about the generalizability and validity of the results from clinical trials. Here we identify predictors of intervention participation and study retention of HIV negative concordant cohabitating couples in a randomized control trial in Zambia designed to reduce HIV risk from concurrent sexual partners.
Methods. Ten government clinics in Lusaka and Ndola, Zambia were randomized to receive the intervention or control. After couples completed Couples' Voluntary Counseling and Testing they were invited to enroll in the study. Couples receiving the behavioral intervention discussed the importance and method of protecting your partnership from HIV infection. Couples in the control intervention received messages on good health practices for non-communicable and neglected tropical diseases. Logistic regression analyses were conducted to identify predictors for intervention participation and study retention, defined as couples making a baseline and first study visit as "Intervention", and couples who were enrolled and made at least one post-intervention follow-up visit as "Retained". The comparison group was couples who completed the baseline questionnaire only and did not return for the intervention or follow-up.
Results. Of 1,812 couples completing the baseline visit, 1,243 returned to receive an intervention (69%) and of those 1,163 (93%) were retained. A higher number of children in the household under age 16 (adjusted odds ratio per additional child, aOR=1.15;95%CI:1.05-1.26), having previously attended couples counseling (aOR=1.32;95%CI:1.03-1.68), the woman partner having a history of sexually transmitted infection (STI) treatment (aOR = 2.53; 95%CI:1.23-5.19), and lower sex frequency (aOR =1.02;95%CI:1.01-1.02) were associated with returning for the intervention visit. Post-intervention, couples with older women partners (aOR = 1.04 per year increase;95%CI:1.00-1.08) were more likely to be retained and couples having less frequent sex due to having a baby/post-partum abstinence (aOR =0.29;95%CI:0.095-0.881) were less likely to be retained.
Conclusion. This clinical trial is designed to reduce HIV incidence among concordant negative couples in high-risk areas. Given predictors of intervention participation and retention, the trial findings will be most generalizable to couples who had previously received CVCT, who have younger children, but not infants, less frequent sex, a woman partner who has been treated for an STI, and older women partners.
Table of Contents
TABLE OF CONTENTS
HIV and Sub-Saharan Africa 1
Couples and HIV 2
HIV Prevention Techniques 2
Male Circumcision 3
Pre-Exposure Prophylaxis (PrEP) 4
Couples Counseling/Testing 6
Negotiated Safety 7
CHAPTER II: MANUSCRIPT 8
SOV RCT Study Design 10
CHAPTER III: PUBLIC HEALTH IMPLICATIONS 35
About this Master's Thesis
|Subfield / Discipline|
|Committee Chair / Thesis Advisor|
|Intervention and Retention Predictors for a Couples' HIV Intervention Randomized Control Trial ()||2018-08-28||
|NIH Aim3_Emory CR Approval Letter_07Sep16_exp08Sep17.pdf ()||2018-08-28||