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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. [ABSTRACT FROM AUTHOR]

The male condom is the most cost-effective method for prevention of HIV and other sexually transmitted infections (STIs), yet in high-burden countries, promotion of its use remains difficult to achieve, especially among high-risk individuals. This review reports on women's perspectives of male condom use and identifies outcome measures that will assist in understanding barriers to male condom use in a South African setting. The Boolean search method was used to retrieve literature, from which 18 studies met the inclusion criteria. The use of the male condom was generally low and inconsistent. Use was higher among women who engaged in transactional sex. Most women had difficulty in negotiating condom use with their partners, particularly if they were in male-dominated relationships or were financially dependent on their partner. Women with higher education levels were able to negotiate use more easily. Interventions for assertive negotiation skills were useful. However, the stigma of infidelity and HIV infection are barriers to condom use. Incorrect use further reduces protection. This review emphasises that women are a vulnerable group who are not always able to control their own protection. Further implementation of the health policies promoting interventions for condom use are required to assist women in taking control of their own protection. Intervention measures should be adapted to include the male population so that they understand and accept condom use. Education to address unequal gender dynamics within relationships is also essential. Much work is required to make women feel less vulnerable in their relationships. [ABSTRACT FROM AUTHOR]

Background: We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes. Methods: In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the "Protect Your Family" intervention (EI; 6 CHCs; n = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus "Protect Your Family" sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes. Results: In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no differences in maternal adherence at 32 weeks, reported infant adherence at 6 weeks, or PMTCT and HIV knowledge by study condition over time. Conclusion: The enhanced intervention administered by trained lay health workers did not have any salutary impact on HIV infant status, ART adherence, HIV and PMTCT knowledge. Trial registration clinicaltrials.gov: number NCT02085356 [ABSTRACT FROM AUTHOR]

Introduction: Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity., Methods: The HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants' non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods., Discussion: The NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting., Trial Registration: Pan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019., (© 2022. The Author(s).)

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., (© 2022. The Author(s).)

Two studies evaluating the same behavioural intervention were conducted in two areas in the KwaZulu-Natal province of South Africa using a randomized pre-test post-test control group design for study 1 (peri-urban) and a pre-test post-test design without a control group for study 2 (rural). The intervention included discussions and skills training on: (1) notions of masculinity, manhood, and responsibility, (2) personal and sexual relationships, (3) general communication skills, and (4) alcohol and other substance use. The intervention was aimed at men between 18 and 35 years of age. Measures of attitude, subjective norms, perceived behavioural control and intention for condom use, human immunodeficiency virus (HIV) testing, reduction of alcohol and drug use, avoiding sex while intoxicated, and avoiding sex with intoxicated people were assessed using a facilitator-administered questionnaire. The results for study 1 showed that 4 of the 19 variables scored significantly different at baseline and that all 19 variables showed no significant changes between pre-test and post-test. For study 2, one significant difference was found for attitude towards avoiding sex when one is intoxicated. Overall, the intervention had minimal success with just one area of positive effect. Further development and testing of this programme is recommended before it can be considered for broader scale implementation.

Background: We evaluate the impact a multicomponent, behavioural, prevention of mother to child transmission (PMTCT), cluster randomised controlled trial on HIV stigma reduction among perinatal HIV infected women in rural South Africa., Methods: In a cluster randomised controlled trial, twelve community health centres (CHCs) in Mpumalanga Province, South Africa, were randomised; pregnant women living with HIV enrolled received either: A Standard Care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n =357), or an Enhanced Intervention (EI) condition of SC PMTCT plus the 'Protect Your Family' intervention (EI; 6 CHCs; n =342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions; those in the EI, four antenatal and two postnatal group PMTCT sessions, including stigma reduction, led by trained lay health workers. Maternal PMTCT, HIV knowledge and HIV related stigma were assessed. The impact of the EI was ascertained on stigma reduction (baseline, 12 months postnatally). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention., Results: In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed prenatally at baseline and at 12 months (59.5%) postnatally. Baseline scores of overall HIV related stigma and the four scale factors (personalised stigma, disclosure concerns, negative self-image, and concern public attitudes) decreased at follow-up in the intervention group, while baseline scores of overall stigma and three scale factors (personalised stigma, negative self-image, and concern public attitudes) increased at follow-up in the control group. Using longitudinal analyses, Model 1, which included time-invariant predictors of stigma assessed over the two time periods of baseline and 12 months, increases in stigma from baseline to 12 months were associated with being unemployed, having been diagnosed with HIV before the current pregnancy, and alcohol use. In Model 2, which included time-varying predictors, lower stigma scores were associated with participation in the intervention, greater male partner involvement, and consistent condom use., Conclusion: The enhanced PMTCT intervention, including stigma reduction, administered by trained lay health workers had a significant effect on the reduction of HIV related stigma., Trial Registration: clinicaltrials.gov: number NCT02085356.