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Try out PMC Labs and tell us what you think. Learn More. Contributors: LD deed the study, obtained the funding, directed the implementation of the study, wrote the first draft of the report, NM contributed to the de of the study, participated in implementation of the study, conducted the statistical analyses, wrote and edited portions of the report, VH, MJ, KF contributed to the de of the study, participated in the implementation of the study, and edited the draft of the report, TN led the implementation of the study, supervised the study staff, edited the report, HVR contributed to the de of the study, directed the implementation of the study, edited the draft of the report.
Using a randomized controlled de, we tested the efficacy of a behavioral couples-based intervention aimed to increase CHTC. Couples were recruited from the community e. Couples were excluded if mutual HIV serostatus disclosure had occurred.
Assessments occurred at baseline, and 3- 6- and 9-months post-intervention. Eligible couples attended a group session hours after which randomization occurred. Intervention topics included communication skills, intimate partner violence, and HIV prevention. Our primary outcomes were CHTC and sexual risk behaviour. Overall, couples were enrolled. There were no group differences in unprotected sex.
Improved and earlier access to HIV treatment are facilitating a reduced HIV burden 3but complicating issues hinder progress in this context 4. Therefore, couples-based approaches have been recommended as a way to leverage partner influence 8.
However, factors such as low marriage rates and infrequent cohabitation 9 a result of employment-related migration render unique challenges for couples-based approaches. Efforts to increase HIV testing have paid less attention to innovative strategies that may combat barriers to uptake. Among a myriad of challenges e. research has found that CHTC promotes sexual risk reduction, especially among serodiscordant partnerships 11 - While CHTC itself addresses aspects of relationships such as communication, few couples-based interventions in SSA have focused on the role of other relationship dynamics such as satisfaction, intimacy, or gender-based power.
The direction of influence of these dynamics on behaviors such as sexual risk behavior, HIV serostatus disclosure, and HIV testing has been inconsistent 14 - However, couples-based studies in SSA have illustrated the importance of relationship dynamics, including trust and commitment 17and identified the crucial role that partners can play in the context of HIV.
Therefore, there is a need for interventions that target couples, increase uptake of CHTC, and examine the role of relationship dynamics on HIV testing and sexual risk behavior.
Based on our prior work and that of others, we also investigated whether the intervention would reduce sexual risk behavior 14 - Our hypothesis was that the intervention would lead to increases in CHTC and declines in sexual risk behavior. The intervention was conducted with the understanding and consent of each participant. Additional details on procedures and intervention have been published ly Inclusion criteria specified couples aged betweenwhose relationship was at least 6 months, were not in a polygamous marriage, and both partners indicated each other as their primary partner to whom they were committed and with whom they had sexual relations.
The intervention was not appropriate for couples experiencing current intimate partner violence IPVbut we did not exclude couples for past history of IPV, as this would limit generalizability. Rather, we excluded and provided referrals for couples reporting current or recent severe violence physical or sexual violence in prior 6 months.
Participants were recruited between March 16 and August 24 by trained recruiters using active and passive strategies. Active strategies included approaching couples in public areas such as markets, taxi ranks, and community events. Recruiters worked in male-female teams, as we found in prior research that couples respond well to mixed-gender teams Passive strategies included posting flyers.
All recruitment activities were conducted using a mobile caravan with two private rooms, in which partners could be interviewed separately. The caravans facilitated a wide geographic catchment area, and were used for recruitment, screening, conducting baseline and follow-up surveys, and delivering intervention sessions. After providing verbal consent, each partner completed a short initial screening, assessing key eligibility criteria relationship length, age, sexually active, polygamous marriage. This could be conducted by phone or in-person. If both partners screened separately were eligible, then a secondary screening occurred, which included written informed consent, either immediately after initial screening, or at a later time.
Following completion of secondary screening, eligible couples were invited to enroll, and after completing informed consent, completed a baseline survey. Couples who remained eligible after the baseline survey attended the next scheduled first group session, with a target of 20 couples per session. Couples were randomized at the completion of the first group session.
The control condition only received the first group session and participated in subsequent follow-up assessments. Intervention couples received an additional group session and four couples counseling sessions. Randomization was conducted at the couple level, using permuted-block randomization of three different block sizes, 8, 10, and 12, in order to blind staff as well as participants to the next asment. Allocation concealment was achieved by opaque envelopes. The random sequence was generated by the study statistician N.
Randomization was conducted by the Project Director T. Due to the nature of the intervention, masking was not possible. Therefore, neither the staff nor participants were unaware of group asment. All couples participated in the first group session. This was four hours, and co-led by a pair of male-female facilitators. The format was interactive, and materials covering local resources and referrals were provided. Occurring one week later, Session 2 was delivered to intervention couples in single-gender groups contemporaneously.
This was a smaller group of couples, led by a gender-matched facilitator and lasted approximately four hours. These sessions were delivered in the study caravan to ensure privacy. Couples ased to the control condition were eligible to participate in a condensed form of the couples counseling sessions following the completion of their participation 9-month follow-up. Follow-up assessments were done at 3- 6- and 9-month post-randomization. The surveys contained several standardized scales assessing relationship functioning, sexual behavior, and demographic information, and mirrored the baseline assessment.
Couples completed their surveys separately but simultaneously. The primary outcomes were participation in CHTC and unprotected sex.
This was determined by the couple participating in CHTC with our study staff a testing counselor separate from assessment and intervention staff. We hypothesized that the proportion of participants who participated in CHTC by 9-month follow-up would be higher in the intervention group than in the control group. We also hypothesized that the time to participation in CHTC would be shorter in the intervention group relative to the control group. For sexual risk behavior, we hypothesized that intervention participants would report fewer acts of unprotected sexual intercourse with primary sex partners relative to the control group.
The analyses followed an intent-to-treat approach. First, we compared the proportion of couples that had participated in CHTC by 9 months between the two arms. A log rank test was used for a time-to-event analysis across the two groups. For the outcome of unprotected sex acts with the enrolled partner in the last 3 months, a negative binomial regression model ing for couple clustering was used, with an offset for the of sex acts with partner in the last three months.
The trial was registered in the US via the clinicaltrials. We randomized couples couples to intervention, to control. Two couples retrospectively were found to have already mutually disclosed and thus were ineligible for the study. During follow-up, 6 couples broke up and 16 couples were lost to follow-up, although our attrition was much lower than assumed for sample size calculations. Please see Figure 1 for the trial profile with additional details. Baseline characteristics of the sample are included in Table 1. We checked that baseline characteristics were balanced across the two groups.
At the couple level, all characteristics were balanced. The female partner was HIV-positive in one of three discordant couples. One adverse event occurred during the course of the trial; a couple broke up and the male partner attributed their break-up to trial participation although the female partner did not. Our study demonstrated the efficacy of a relationship-focused, couples-based intervention on participation in CTHC as compared to control. The hypotheses were supported as the intervention successfully promoted CHTC, and a rapid uptake of this service. Further, the vast majority of participating couples had not disclosed the of any prior HIV test to their study partner at baseline.
Both findings indicate that the study reached a population in need of intervention. High retention rates for both intervention activities and follow-up assessments in a sample of couples with low rates of cohabitation indicate that a couples-focused approach is feasible even with non-married and non-cohabitating couples.
Findings support and extend recent studies with couples from similar contexts. Second, a couples-based approach facilitates engaging male partners—often a challenge in the SSA context. For example, men may perceive health-care clinics as aversive and avoid attending them with their female partners 22 —targeting couples may address this problem. Similar efforts have focused on improving uptake of CHTC by pregnant women and their partners Finally, the findings mirror the of a meta-analysis of HIV-related interventions that compared interventions delivered to couples to those delivered to individuals We identified more newly diagnosed HIV-positive individuals among couples who participated in CHTC in the intervention group, as compared to the control group although the difference was not statistically ificantthereby demonstrating the utility of the intervention for individuals missed by other testing efforts.
Findings for unprotected sex were not ificant at final follow-up, the reductions at first follow-up reflect a common finding of dissipating effects in behavioral prevention trials Prior recommendations include providing booster sessions to promote continued behavioral risk reduction. Our high retention suggests that couples may be willing to attend additional sessions. Nonetheless, the ificant reduction at 3-months post-intervention indicates that the intervention also positively impacted unprotected sex in the short term, in addition to its impact on CHTC. To our knowledge, this is one of the first interventions to use CHTC as its outcome.
CHTC has been praised for its ability to reduce sexual risk behavior and improve disclosure and thus touted as a high-leverage intervention 27yet uptake has been relatively low, even in areas where it is widely available Thus, this intervention represents a step forward in improving uptake. Our outcome measure CHTC was conducted and verified by our team, as opposed to being by self-report. Further, our intervention was implemented by members of the local community in conditions reflective of local resources, thereby supporting subsequent implementation Future efforts should examine whether efficacy translates into effectiveness in non-research settings.
There are some limitations to the .
The intervention and control groups were not time and attention-matched; intervention couples were exposed to more sessions than control couples. The sexual behavior outcome was based on self-report, and thus subject to social desirability and reporting bias. But this bias is likely the same across arms, therefore only impacting the overall levels of reported unprotected sex.
The trial was conducted in a rural community with high migration, high unemployment, and low marriage rates that could affect generalizability to other contexts. Nonetheless, this contrasts to other couples-based studies as most studies of CHTC retain samples recruited from HIV clinics, as opposed to community-based settings. Although this could limit generalizability to broader samples of couples e.Michigan women seeking couples
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