Two-way associations between relationship quality and uptake of couples health screening including HIV testing and counselling together: quantitative analysis of a couples cohort in rural South Africa.

In the context of a couples cohort established to evaluate an optimised couples-focused behavioural intervention in rural South Africa, we examined: (1) Is couples' relationship quality (RQ) associated with couples HIV testing and counselling (CHTC) uptake? (2) Does CHTC uptake or the intervention components uptake improve subsequent RQ? Enrolled couples, (n = 218), previously naïve to couples HIV testing, were invited to two group sessions and offered four couples counselling sessions (CS1-CS4), as part of the intervention and administered a questionnaire individually at baseline, four weeks, and four months, which included item-scales to measure RQ: satisfaction, intimacy, dyadic trust, conflict, and mutual constructive communication. Logistic models indicated that no baseline RQ measures were significantly associated with CHTC uptake. Linear regression models showed that CHTC uptake before four weeks assessment significantly improved couples' satisfaction and trust at four weeks, and intimacy at four months. Attending at least one CS was associated with increased satisfaction, intimacy, and decreased conflict within couples at four weeks; the improvement in intimacy was sustained at four months. Consistent with the theoretical interdependence model, our findings suggest that CHTC and CS seemed to strengthen aspects of relationship quality, possibly leading to further collaboration in managing lifestyle changes and treatment adherence.

Implementation of the advanced HIV disease care package with point-of-care CD4 testing during tuberculosis case finding: A mixed-methods evaluation.

During TB-case finding, we assessed the feasibility of implementing the advanced HIV disease (AHD) care package, including VISITECT CD4 Advanced Disease (VISITECT), a semiquantitative test to identify a CD4≤200cells/µl. Adult participants with tuberculosis symptoms, recruited near-facility in Lesotho and South-Africa between 2021-2022, were offered HIV testing (capillary blood), Xpert MTB/RIF and Ultra, and MGIT culture (sputum). People living with HIV (PLHIV) were offered VISITECT (venous blood) and Alere tuberculosis-lipoarabinomannan (AlereLAM, urine) testing. AHD was defined as a CD4≤200cells/µl on VISITECT or a positive tuberculosis test. A CD4≤200cells/µl on VISITECT triggered Immy cryptococcal antigen (Immy CrAg, plasma) testing. Participants were referred with test results. To evaluate feasibility, we assessed i) acceptability and ii) intervention delivery of point-of-care diagnostics among study staff using questionnaires and group discussions, iii) process compliance, and iv) early effectiveness (12-week survival and treatment status) in PLHIV. Predictors for 12-week survival were assessed with logistic regression. Thematic content analysis and triangulation were performed. Among PLHIV (N = 676, 48.6% of 1392 participants), 7.8% were newly diagnosed, 81.8% on ART, and 10.4% knew their HIV status but were not on ART. Among 676 PLHIV, 41.7% had AHD, 29.9% a CD4≤200cells/µl and 20.6% a tuberculosis diagnosis. Among 200 PLHIV tested with Immy CrAg, 4.0% were positive. The procedures were acceptable for study staff, despite intervention delivery challenges related to supply and the long procedural duration (median: 73 minutes). At 12 weeks, among 276 PLHIV with AHD and 328 without, 3.3% and 0.9% had died, 84.8% and 92.1% were alive and 12.0% and 7.0% had an unknown status, respectively. Neither AHD nor tuberculosis status were associated with survival. Implementing AHD care package diagnostics was feasible during tuberculosis-case finding. AHD was prevalent, and not associated with survival, which is likely explained by the low specificity of VISITECT. Challenges with CD4 testing and preventive treatment uptake require addressing.

Fee for home delivery and monitoring of antiretroviral therapy for HIV infection compared with standard clinic-based services in South Africa: a randomised controlled trial.

BACKGROUND: Home delivery and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistical barriers, and could increase individual ART adherence and viral suppression. With client payment and sufficient health benefits, this strategy could be scalable. The aim of the Deliver Health Study was to test the acceptability and efficacy of a user fee for home ART monitoring and delivery. METHODS: We conducted a randomised trial, the Deliver Health Study, of a fee for home delivery of ART compared with free clinic ART delivery in South Africa. People with HIV who were 18 years or older and clinically stable (including CD4 count >100 cells per µL and WHO HIV stage 1-3) were randomly assigned to: (1) fee for home delivery and monitoring of ART, including community ART initiation if needed; or (2) clinic-based ART (standard of care). The one-time fee for home delivery (ZAR 30, 60, and 90; equivalent to US$2, 4, 6) was tiered on the basis of participant income. The primary outcomes were recorded fee payment and acceptability assessed via questionnaire. The key virological secondary outcome was viral suppression with the difference between study groups assessed through robust Poisson regression including participants with viral load measured at exit (modified intention-to-treat analysis). This trial is registered on ClinicalTrials.gov (NCT04027153) and is complete, with analyses ongoing. FINDINGS: From Oct 7, 2019, to Jan 30, 2020, 162 participants were enrolled; 82 were randomly assigned to the fee for home delivery group and 80 to the clinic-based group, with similar characteristics at baseline. Overall, 87 (54%) participants were men, 101 (62%) were on ART, and 98 (60%) were unemployed. In the home delivery group, 40 (49%), 33 (40%), and nine (11%) participants qualified for the ZAR 30, 60, and 90 fee, respectively. Median follow-up was 47 weeks (IQR 43-50) with 96% retention. 80 (98%) participants paid the user fee, with high acceptability and willingness to pay. In the modified intention-to-treat analysis of 155 (96%) participants who completed follow-up, fee for home delivery and monitoring statistically significantly increased viral suppression from 74% to 88% overall (RR 1·21, 95% CI 1·02-1·42); and from 64% to 84% among men (1·31, 1·01-1·71). INTERPRETATION: Among South African adults with HIV, a fee for home delivery and monitoring of ART significantly increased viral suppression compared with clinic-based ART. Clients' paying a fee for home delivery and monitoring of ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result. Home ART delivery and monitoring, potentially with a user fee to offset costs, should be evaluated as a differentiated service delivery strategy to increase access to care. FUNDING: National Institutes of Mental Health.

Protocol: evaluation of an optimised couples-focused intervention to increase testing for HIV in rural KwaZulu-Natal, South Africa, the Igugu Lethu ('Our treasure') cohort study.

BACKGROUND: Between 2012 and 2015, the Uthando Lwethu (UL) study demonstrated that a theory-based behavioural couples-focused intervention significantly increased participation in couples HIV testing and counselling (CHTC) among South African couples who had never previously tested for HIV together or mutually disclosed their HIV status, 42% compared to 12% of the control group at 9 months follow-up. Although effective, we were nonetheless concerned that in this high prevalence setting the majority (58%) of intervention couples chose not to test together. In response we optimised the UL intervention and in a new study, 'Igugu Lethu', we are evaluating the success of the optimised intervention in promoting CHTC. METHODS: One hundred eighty heterosexual couples, who have been in a relationship together for at least 6 months, are being recruited and offered the optimised couples-focused intervention. In the Igugu Lethu study, we have expanded the health screening visit offered to couples to include other health conditions in addition to CHTC. Enrolled couples who choose to schedule CHTC will also have the opportunity to undertake a random blood glucose test, blood pressure and BMI measurements, and self-sample for STI testing as part of their health screening. Individual surveys are administered at baseline, 4 weeks and 4 months follow-up. The proportion of couples who decide to test together for HIV will be compared to the results of the intervention arm in the UL study (historical controls). To facilitate this comparison, we will use the same recruitment and follow-up strategies in the same community as the previous UL study. DISCUSSION: By strengthening communication and functioning within the relationship, the Igugu Lethu study, like the previous UL study, aims to transform the motivation of individual partners from a focus on their own health to shared health as a couple. The Igugu Lethu study findings will answer whether the optimised couples-focused behavioural intervention and offering CHTC as part of a broader health screening for couples can increase uptake of CHTC by 40%, an outcome that would be highly desirable in populations with high HIV prevalence. TRIAL REGISTRATION: Retrospectively registered. ISRCTN Registry ISRCTN 46162564 Registered on 26th May 2022.

Feasibility of implementing the advanced HIV disease care package as part of community-based HIV/TB activities: a mixed-methods study protocol.

INTRODUCTION: Although the advanced HIV disease (AHD) care package reduces morbidity and mortality in people with AHD (defined in people living with HIV as WHO stage 3 or 4, CD4 count <200 cells/µL or age <5 years), it is barely implemented in many countries. A novel point-of-care CD4 test rapidly identifies AHD. We evaluate the feasibility of implementing the AHD care package as part of community-based HIV/tuberculosis services. METHODS AND ANALYSIS: This two-phased study is guided by the Medical Research Council framework for evaluation of complex interventions. Stage 1 is a stakeholder consultation to define tools and indicators to assess feasibility of the AHD care package. Stage 2 is the implementation of the AHD care package during a facility-based tuberculosis diagnostic accuracy study in high-burden HIV/tuberculosis settings. Consenting adults with tuberculosis symptoms in two sites in Lesotho and South Africa are eligible for inclusion. HIV-positive participants are included in the feasibility study and are offered a CD4 test, a tuberculosis-lipoarabinomannan assay and those with CD4 count of ≤200 cells/µL a cryptococcal antigen lateral flow assay. Participants are referred for clinical management following national guidelines. The evaluation includes group discussions, participant observation (qualitative strand) and a semistructured questionnaire to assess acceptability among implementers. The quantitative strand also evaluates process compliance (process rating and process cascade) and early outcomes (vital and treatment status after twelve weeks). Thematic content analysis, descriptive statistics and data triangulation will be performed. ETHICS AND DISSEMINATION: The National Health Research and Ethics Committee, Lesotho, the Human Sciences Research Council Research Ethics Committee and Provincial Department of Health, South Africa and the Ethikkommission Nordwest- und Zentralschweiz, Switzerland, approved the protocol. Dissemination will happen locally and internationally at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04666311.

Social Influence and Uptake of Couples HIV Testing and Counselling in KwaZulu-Natal, South Africa.

Social influences may create a barrier to couples HIV testing and counselling (CHTC) uptake in sub-Saharan Africa. This secondary analysis of data collected in the 'Uthando Lwethu' randomised controlled trial used discrete-time survival models to evaluate the association between within-couple average 'peer support' score and uptake of CHTC by the end of nine months' follow-up. Peer support was conceptualised by self-rated strength of agreement with two statements describing friendships outside of the primary partnership. Eighty-eight couples (26.9%) took up CHTC. Results tended towards a dichotomous trend in models adjusted only for trial arm, with uptake significantly less likely amongst couples in the higher of four peer support score categories (OR 0.34, 95% CI 0.18, 0.68 [7-10 points]; OR 0.53, 95% CI 0.28, 0.99 [≥ 11 points]). A similar trend remained in the final multivariable model, but was no longer significant (AOR 0.59, 95% CI 0.25, 1.42 [7-10 points]; AOR 0.88, 95% CI 0.36, 2.10 [≥ 11 points]). Accounting for social influences in the design of couples-focused interventions may increase their success.

Optimising a couples-focused intervention to increase couples' HIV testing and counselling using the person-based approach: a qualitative study in Kwa-Zulu Natal, South Africa.

OBJECTIVES: This qualitative study explored how to optimise a couples-focused intervention to promote couples HIV testing and counselling (CHTC). SETTING: Community setting in Kwa-Zulu Natal, South Africa. PARTICIPANTS: Qualitative interviews were conducted with 20 couples who had participated in a couples-focused intervention and five staff members delivering the intervention. Partners were interviewed individually by researchers of the same gender. INTERVENTION: A couples-focused intervention comprised of two group sessions and four couples counselling sessions was previously shown to significantly increase uptake to CHTC in Kwa-Zulu Natal, South Africa. However, more than half of couples participating in the intervention still chose not to test together during follow-up. ANALYSIS: The transcripts were analysed using the table of changes from the person-based approach. Proposed optimisations were discussed with a community group to ensure the intervention was as persuasive and acceptable as possible. RESULTS: Many couples found it challenging to discuss CHTC with their partner due to an implied lack of trust. Optimisations to the intervention were identified to increase readiness to discuss CHTC, including education about serodiscordance, discussions about CHTC by peer mentors and open discussion of personal barriers to CHTC during couples' counselling sessions. Additional training for staff in open questioning techniques could help them feel more comfortable to explore couples' perceived barriers to CHTC, rather than advising couples to test. A logic model was developed to show anticipated mechanisms through which the optimised intervention would increase uptake to CHTC, including increasing knowledge, increasing positive outcome beliefs and managing negative emotions. CONCLUSIONS: In-depth qualitative research informed optimisations to a couples-focused intervention for further evaluation in South Africa to encourage uptake to CHTC. Suggestions are made for optimal methods to gain open feedback on intervention experiences where participants may be reluctant to share negative views.

Lottery incentives have short-term impact on ART initiation among men: results from a randomized pilot study.

INTRODUCTION: Among people living with HIV in South Africa, viral suppression is lower among men than women. The study aim was to test the impact of lottery incentives, which reward positive health choice (e.g. antiretroviral therapy (ART) linkage) with a chance to win a prize, on strengthening the HIV care continuum including ART initiation and viral suppression for men. METHODS: We conducted a randomized, prospective trial of lottery incentives in the context of HIV testing and linkage to ART in rural KwaZulu-Natal, South Africa. Men living with HIV were randomly allocated to: lottery incentives and motivational text messages or motivational text messages only. Lottery prize eligibility was conditional on clinic registration, ART initiation, or viral suppression by one, three and six months respectively. After completing each continuum step, participants in the lottery group were notified whether they had won and were encouraged to continue in care. Lottery prizes were either a mobile phone, data or a gift card (valued at R1000/$100). Kaplan-Meier curves were plotted to determine time to ART initiation by study group. The primary outcome was viral suppression at six months. RESULTS: Between November 2017 and December 2018, we tested 740 men for HIV and enrolled 131 HIV-positive men who reported not being on ART. At baseline, 100 (76%) participants were 30 years and older, 95 (73%) were unemployed and the median CD4 count was 472 cells/µL. At study exit, 84% (110/131) of participants had visited a clinic and 62% (81/131) were virally suppressed. Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline. Lottery incentives had an inconclusive effect on clinic registration (RR = 1.21, 95% CI: 0.83 to 1.76) and on viral suppression at six months (RR = 1.13, 95% CI: 0.73 to 1.75) compared to motivational text messages. CONCLUSIONS: Conditional lottery incentives shortened the time to ART initiation among South African men. Behavioural economics strategies strengthen linkage to ART, but the study power was limited to see an impact on viral suppression. CLINICAL TRIAL NUMBER: NCT03808194.

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV.

BACKGROUND: Although couples HIV testing and counseling (CHTC) is effective for facilitating mutual disclosure and linkage to HIV care, uptake remains low. Using a randomized controlled design, we tested the efficacy of a behavioral couples-based intervention aimed to increase CHTC. SETTING: The Vulindlela district of KwaZulu-Natal, South Africa. METHODS: Couples were recruited from the community (eg, markets and community events). Couples were excluded if mutual HIV serostatus disclosure had occurred. Both partners had to report being each other's primary partner and relationship length was at least 6 months. Assessments occurred at baseline, and 3, 6, and 9 months after intervention. Eligible couples attended a group session (3-4 hours) after which randomization occurred. Intervention couples additionally received: one couples-based group session followed by 4 couples' counseling sessions (1-2 hours). Intervention topics included communication skills, intimate partner violence, and HIV prevention. Our primary outcomes were CHTC and sexual risk behavior. RESULTS: Overall, 334 couples were enrolled. Intervention couples were significantly more likely to have participated in CHTC [42% vs. 12% (P ≤ 0.001)]. In addition, their time to participate in CHTC was significantly shorter (logrank P ≤ 0.0001) (N = 332 couples). By group, 59% of those who tested HIV-positive in intervention and 40% of those who tested in control were new HIV diagnoses (P = 0.18). There were no group differences in unprotected sex. CONCLUSIONS: Our intervention improved CHTC uptake-a vehicle for mutual serostatus disclosure and entrée into HIV treatment, both of which exert a significant public health impact on communities substantially burdened by HIV.

Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa.

BACKGROUND: Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men. METHODS: This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load. DISCUSSION: A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men's individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.

'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples.

Despite the important role of social relationships for health and wellbeing, little is known about how primary partners affect adherence to HIV care and treatment. We qualitatively explored how relationship dynamics and partner support influence adherence among couples from KwaZulu-Natal, South Africa. Twenty-four heterosexual couples with at least one HIV-positive partner completed semi-structured interviews on topics including relationship dynamics (intimacy or emotional closeness, communication, violence), experiences with HIV care and treatment and HIV-related social support. The majority of couples were seroconcordant HIV-positive (92%) and both on antiretroviral therapy (ART) (63%). Participants described how primary partners both interfered with and supported adherence. Negative forms of influence included relationship conflict, which resulted in forgetfulness to take pills, and men's attempt to control use of ART. However, participants were more likely to highlight positive forms of influence on adherence, which included social support (instrumental, informational and emotional), intimacy and commitment. The findings also suggest a reciprocal relationship between ART and relationships such that couple ART use may enhance relationship quality. Primary partners are important pillars of support for ART adherence, especially in contexts of high unemployment and poverty. Future interventions that encourage and leverage these supportive relationships could improve ART adherence among heterosexual couples in similar settings.

"If She is Drunk, I Don't Want Her to Take it": Partner Beliefs and Influence on Use of Alcohol and Antiretroviral Therapy in South African Couples.

Alcohol consumption and beliefs about mixing alcohol and ART are associated with decreased adherence to antiretroviral therapy (ART). In this study, we examined how romantic partners influence alcohol and ART use. We conducted semi-structured interviews with 24 HIV-positive individuals and their primary partners (48 individuals) in KwaZulu-Natal, South Africa. Almost 17% of participants spontaneously expressed beliefs that alcohol and ART should not be mixed. Participants who held these beliefs influenced their partners' behaviors by either discouraging the mixing of alcohol and ART, which sometimes resulted in missed pills when drinking, or by helping partners manage their medications when drinking. Other participants encouraged partners to take ART no matter what. Messages on alcohol and ART may need to be refined for ART patients who cannot abstain from alcohol. Primary partners should be included in these education efforts and their influence could be leveraged to help reduce alcohol consumption and maintain adherence.

Power and the association with relationship quality in South African couples: Implications for HIV/AIDS interventions.

INTRODUCTION: Power imbalances within sexual relationships have significant implications for HIV prevention in sub-Saharan Africa. Little is known about how power influences the quality of a relationship, which could be an important pathway leading to healthy behavior around HIV/AIDS. METHODS: This paper uses data from 448 heterosexual couples (896 individuals) in rural KwaZulu-Natal, South Africa who completed baseline surveys from 2012 to 2014 as part of a couples-based HIV intervention trial. Using an actor-partner interdependence perspective, we assessed: (1) how both partners' perceptions of power influences their own (i.e., actor effect) and their partner's reports of relationship quality (i.e., partner effect); and (2) whether these associations differed by gender. We examined three constructs related to power (female power, male equitable gender norms, and shared power) and four domains of relationship quality (intimacy, trust, mutually constructive communication, and conflict). RESULTS: For actor effects, shared power was strongly and consistently associated with higher relationship quality across all four domains. The effect of shared power on trust, mutually constructive communication, and conflict were stronger for men than women. The findings for female power and male equitable gender norms were more mixed. Female power was positively associated with women's reports of trust and mutually constructive communication, but negatively associated with intimacy. Male equitable gender norms were positively associated with men's reports of mutually constructive communication. For partner effects, male equitable gender norms were positively associated with women's reports of intimacy and negatively associated with women's reports of conflict. CONCLUSIONS: Research and health interventions aiming to improving HIV-related behaviors should consider sources of shared power within couples and potential leverage points for empowerment at the couple level. Efforts solely focused on empowering women should also take the dyadic environment and men's perspectives into account to ensure positive relationship outcomes.

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.

BACKGROUND: Couples-based HIV counseling and testing (CHCT) is a proven strategy to reduce the risk of HIV transmission between partners, but uptake of CHCT is low. We describe the study design of a randomized controlled trial (RCT) aimed to increase participation in CHCT and reduce sexual risk behavior for HIV among heterosexual couples in rural KwaZulu-Natal, South Africa. We hypothesize that the rate of participation in CHCT will be higher and sexual risk behavior will be lower in the intervention group as compared to the control. METHODS/DESIGN: Heterosexual couples (N=350 couples, 700 individuals) are being recruited to participate in a randomized trial of a couples-based intervention comprising two group sessions (one mixed gender, one single gender) and four couples' counseling sessions. Couples must have been in a relationship together for at least 6 months. Quantitative assessments are conducted via mobile phones by gender-matched interviewers at baseline, 3, 6, and 9 months post-randomization. Intervention content is aimed to improve relationship dynamics, and includes communication skills and setting goals regarding CHCT. DISCUSSION: The Uthando Lwethu ('our love') intervention is the first couples-based intervention to have CHCT as its outcome. We are also targeting reductions in unprotected sex. CHCT necessitates the testing and mutual disclosure of both partners, conditions that are essential for improving subsequent outcomes such as disclosure of HIV status, sexual risk reduction, and improving treatment outcomes. Thus, improving rates of CHCT has the potential to improve health outcomes for heterosexual couples in a rural area of South Africa that is highly impacted by HIV. The results of our ongoing clinical trial will provide much needed information regarding whether a relationship-focused approach is effective in increasing rates of participation in CHCT. Our intervention represents an attempt to move away from individual-level conceptualizations, to a more integrated approach for HIV prevention. TRIAL REGISTRATION: Study Name: Couples in Context: An RCT of a Couples-based HIV Prevention InterventionClinicalTrials.gov identifier: NCT01953133.South African clinical trial registration number: DOH-27-0212-3937.