Study Design and Setting
A cross-sectional study was conducted in three hospitals in Njombe region, Tanzania between June and September 2015. Njombe is Tanzania’s highest prevalence region where 14.8% of adults are infected with HIV [21]. Study facilities included peri-urban Kibena Regional Hospital, urban Makambako Town Hospital, and the rural, Faith-Based Ilembula Designated District Hospital. Each facility had a dedicated, onsite VCT center, and offered PITC to inpatients and outpatients. These three facilities were selected because of their high testing volume, in consultation with regional authorities.
Study Population and Eligibility Criteria
Men and women newly diagnosed with HIV through VCT or PITC at the three study sites were screened for study eligibility. Eligibility criteria for index clients were: newly diagnosed with HIV, 18 years or older, not pregnant, had current sexual partner or had partner in the past 24 months. Pregnant women were excluded from the study since a form of partner services already exists within antenatal care services in Tanzania—pregnant women are requested to bring their sexual partner in for HIV testing. Referred sexual partners were enrolled in this study if they met the eligibility criteria for the study: 18 years or older, were listed as having been a sexual partner within the last 24 months, and had locator information, and consented to participate.
Sample Size
We based our sample size calculation on an assumption that index clients would list an average of one sexual partner, and that 51% of partners would come to the facility following notification, as seen in the Malawi study [10]. Based on these assumptions, a sample size of 384 index clients was needed to detect a similar rate of attendance among sexual partners with 85% power (α = 0.05, two-sided test). The design effect (DEFF) was set at 1.0 because we expected minimal variation between facilities. The sample size formula for a single cross-sectional survey was:
$${\text{n}} = \frac{{1.96^{2} {\text{p}}(1 - {\text{p}})({\text{DEFF}})}}{{{\text{d}}^{2} }} = \frac{{1.96^{2} \times 0.51(1 - 0.51)(1.0)}}{{(0.05)^{2} }} = 384.$$
Study Procedures
Individuals newly diagnosed with HIV through PITC or VCT were referred to onsite researchers, who were also HIV counselors, and screened for study eligibility. Written informed consent was obtained from interested and eligible participants, referred to as “index clients.” Enrolled index clients first answered a brief questionnaire that collected demographic information, general sexual history, history of intimate partner violence (IPV), and then were asked to list current or past (within 24 months) sexual partners. Clients with a history of IPV were noted, so that study staff could provide appropriate counseling. Written consent, separate from participation in the study, was obtained before the index client listed partners. Index clients were asked to list as many partners as they could, with locator information, duration, status (past or current) and type of relationship for each partner.
The study team member then informed the index client about the three types of partner notification (passive, contract, and provider) and the index client selected the preferred approach to notify each of the listed sexual partners. Partner notification by study staff was only initiated after obtaining consent from the index client. For passive referral, the study staff and the client agreed on a timeline when the index client would bring in or refer listed partners. Index clients received a pre-printed study referral card to give to partners, if they chose. If index clients did not bring in partners by the agreed date, study staff contacted the index client by phone to encourage him or her to complete the referral. For contract referral, the study staff initiated partner notification if after 2 weeks the index client had failed to bring in the sexual partner. For provider referral, the study staff contacted partners directly by phone within 24 h, and read pre-scripted information from the referral card, requesting partners to come for HTS. No information on the identity of the index client was provided to the partner. Study staff contacted partners three to five times before they were declared lost to follow-up (unless the partner declined the referral). Index clients were linked to partners using an ID code. Partners who came for services without the index client had been contacted in advance by the study team member and told where to come in the health facility, so the study team member was able to link the partner to the index client.
During partner listing, the study staff assisted index clients to assess the risk of IPV specific to each listed sexual partner, using a standardized set of questions. Any sexual partners the index client indicated might react with violence were excluded from the notification process.
Partners coming for HTS were informed of the study, consented, linked to the index client’s ID, and recorded as successful referrals. Unless already enrolled in an HIV Care and Treatment Centre (CTC), as verified by self-report or a CTC card, all sexual partners were offered HTS following the Ministry of Health, Community Development, Gender, Elderly and Children HIV testing protocols. Partners testing positive for HIV were referred to their chosen CTC using a referral form with a detachable portion which the client could return to the site of the original referral.
Three methods were used to verify study participants’ enrollment at the CTC; (1) returned note signed by CTC staff as confirmation of enrollment, (2) study staff checking CTC registers at the study facilities and at nearby facilities for the names and addresses of those who did not return the referral note, and (3) study staff contacting participants by phone and asking them whether they were already enrolled into CTC (self-report).
Data Management and Analysis
Data were collected using both paper forms and electronic tablets. Paper-based data were entered into ODK data files that had field checks for data quality. Data collected using tablets were uploaded immediately to a server located in Dar es Salaam. Data were cleaned by running queries and reports using STATA version 14.0 and correcting discrepancies. Data were extracted and analyzed using SPSS version 23.
Descriptive statistics were performed to describe the background characteristics of index clients and successfully referred partners. Partners were considered successfully referred if they came to the respective facilities as a result of any notification method, whether or not they tested for HIV. Assessment of differences between sites was conducted and no major differences were seen on study outcome variables. Univariate and multivariate logistic regressions were run to identify predictors of participation in the study among newly diagnosed individuals, and success of referral among listed sexual partners. Backward elimination was used to establish the final logistic model. Covariates were included into the final model if they had a p value <0.25 and/or were known to affect the outcome of interest in previously published studies. Variables dropped out of the original model include: occupation, duration of relationship, and whether sexual partner is a current partner. Table 2 depicts variables that were retained in the final multivariate model and their effect on the study outcome.
Ethical Considerations
The study was conducted with ethical oversight from the Institutional Review Boards (IRBs) of the Johns Hopkins University Bloomberg School of Public Health (IRB 00006116) and the Tanzania National Institute for Medical Research (NIMR/HQ/R.8a/vol.1x/1914) with support from the Njombe regional medical authorities.