Context

3.1.1 The research setting

Kisesa ward is an administrative unit within Magu district in Mwanza region, northwest Tanzania (Figure 3.1). It lies approximately 20 kilometres east of Mwanza city, the regional capital and Tanzania’s second largest city, and includes seven villages, each of which is divided into a number of sub-villages. For the analyses presented in this thesis, sub-villages are categorised as being located in rural areas, along a main tarmacadam road which runs through the study area, or surrounding the study area’s trading centre (Kisesa trading centre). The ward had a population of approximately 32,000 people in 2012, the majority of whom belong to the Sukuma tribe, Tanzania’s largest ethnic group. The study area is predominantly rural in nature with economic activities revolving around small-scale farming and the petty trade of agricultural products such as milk, tomatoes, maize, fish and rice. Per capita income is low, estimated at approximately 340 US dollars per year in 2011 (139).

58 Figure 3.1 Location of Kisesa ward and study area

3.1.2 Kisesa cohort study activities

The primary research activities conducted as part of the Kisesa cohort study include ongoing rounds of biannual demographic surveillance (the demographic surveillance system or DSS), and serological surveys (sero-surveys) which are conducted once every two to three years. Each of these activities are described in detail below.

Demographic surveillance system (DSS)

The DSS constitutes a census of the entire population (i.e. including all children and adults) of the seven villages which make up Kisesa ward, with 28 rounds of the survey having been completed between 1994 and 2013 (see Figure 3.2). At each round all households in the study area (including any new households appearing since the last round of demographic surveillance) are visited by trained fieldworkers. A single individual (usually the head of household, or another well informed household member if the household head is not present) responds on behalf of all household members, reporting information on residence status of each individual (whether alive or dead, whether still living there or moved house within the study area, or out- migrated from the study area), any new or returning household members, spousal and parent-child links within households, pregnancy among

59 women of reproductive age, births, deaths and, since the fifteenth round of the DSS in 2003, number of years of schooling for those aged 5 to 25 (see Appendix 11.2.1 for an example of the household enumeration form used at DSS round 28 in 2013). Response rates during DSS rounds are generally very high (≥98%; households are re-visited several times if nobody is present to respond at the initial visit). For the research presented in this thesis, data from DSS rounds 16 to 27 were linked to the sero-surveillance data (see below), and these data were used as the denominator in quantitative analyses.

Serological surveillance

In addition to the DSS, seven rounds of serological surveillance (sero-surveys) have been completed between 1994 and 2013 (in 1994-1995, 1996-1997, 1999-2000, 2003-2004, 2006-2007, 2010 and 2013; Seros 1 to 7, respectively, see Figure 3.2) as part of the Kisesa cohort study (data from sero-survey rounds 4, 5 and 6 are used as part of this thesis). Eligibility for sero-surveys is based on having been resident at the most recent round of demographic surveillance (for existing household members, having responded ‘yes’ to DSS question ‘Still live here?’, or for new or returning members of the household, classified as ‘resident’ – see DSS enumeration form in Appendix 11.2.1) and being aged 15-44 (Sero1), 15-46 (Sero2) or 15 or older (all subsequent rounds) at the time of the sero-survey. During sero- surveys, eligible individuals are invited to a central location within each village in order to participate. Transport to the sero-survey site is provided free of charge for all study participants. Separate consent is provided for each element of the study (i.e, participants may choose to participate in any single element of the study without being required to participate in other parts of the study), including completion of a structured interview questionnaire with a trained researcher, provision ofa finger- prick blood sample for research HIV testing, and since Sero4 in 2003-2004, optional use of a voluntary mobile or community outreach HTC serviceAll study participants are also offered free medical treatment for any health problems present at the time of the sero-survey, for themselves and any accompanying family members.

During sero-surveys, study participation occurs in the following chronological order: registration, completion of the interview questionnaire, provision of a finger prick blood sample, visit to the study clinician or nurse for a medical consultation, and

60 participation in HTC. Each element of the study takes place in a separate purpose constructed hut or room (making use of existing village infrastructure where possible) in order to ensure privacy. Interview questionnaires are administered by trained, same sex researchers in Swahili or in the local language Sukuma if appropriate, and cover topics on family planning and sexual health, HIV and ART knowledge, partnerships, sexual behaviour and use of HIV and other health services (see Sero6 questionnaire provided as an example of a typical sero-survey questionnaire in Appendix 11.2.2). Data from the DSS can be linked to the sero- survey data using unique identifiers assigned to study participants, providing access to additional information on spousal links between those attending sero-surveys, recent changes in marital status, or periods of in and out-migration from the study area..

Research HIV testing during sero-surveys is anonymous and based on informed consent without results disclosure. During Sero1 whole blood was collected by venepuncture. From Sero2 onwards all samples were collected as dried blood spots on filter paper. HIV testing is performed at the regional reference laboratory at the National Institute for Medical Research (NIMR) in Mwanza city, with serologic diagnosis based on two ELISAs (Enzygnost HIV1/HIV2 (Behring, Marburg, Germany) and Vironostika HIV-MIXT (Organon, Boxtel, the Netherlands) for Seros 1-3, Enzygnost HIV1/HIV2 (Behring, Marburg, Germany) and Uniform 2 (BioMerieux, Boxtel, the Netherlands) for Seros 4-7). At all rounds blood samples with reactive results for both ELISAs were considered to be HIV positive, with Western blot tests used in the case of discordant results at Sero1, and repeat testing of samples using the two ELISA tests from Sero2 onwards.

Participation in sero-surveys has declined over time, from approximately 85% at Sero1 (5,642/6,672 of all those eligible participating) to 55% at Sero6 (6,511/11,946 of all those eligible participating). Table 3.1 below shows the distribution of participation in sero-survey rounds 1 to 6 by sex and age-group. Declines in participation have been greatest among men aged 25-54 living in roadside villages or in the trading centre (140), likely as a result of out-migration for work (the implications of declining participation for the study’s results are considered in the thesis discussion).

61 Table 3.1: Distribution of participation in sero-survey rounds 1-6 by sex and age-group

*Note that all Sero6 figures are preliminary – the final breakdown of Sero6 participation by sex and age-group is not yet available, although the pattern is not expected to change significantly from the figures shown here.

Sero1 Sero2 Sero3 Sero4 Sero5 Sero6*

Eligible Attended (%) Eligible Attended (%) Eligible Attended (%) Eligible Attended (%) Eligible Attended (%) Eligible Attended (%) Men 15-24 1600 1328 (83.0) 1750 1371 (78.3) 1826 1204 (65.9) 2148 1593 (74.2) 2307 1629 (70.6) 2150 1084 (50.4) 25-34 979 806 (82.3) 1054 819 (77.7) 1093 702 (64.2) 1297 859 (66.2) 1241 658 (53.0) 1026 428 (41.7) 35-44 562 455 (81.0) 670 503 (75.1) 756 508 (67.2) 913 600 (65.7) 863 468 (54.2) 808 367 (45.4) 45-54 31 19 (61.3) 102 81 (79.4) 434 289 (66.6) 506 331 (65.4) 594 357 (60.1) 606 282 (46.5) 55+ 2 0 (0) 7 3 (42.9) 527 375 (71.2) 639 481 (75.3) 643 442 (68.7) 688 364 (52.9) Overall participation men 3174 2608 (82.2) 3583 2777 (77.5) 4636 3078 (66.4) 5503 3864 (70.2) 5648 3554 (62.9) 5278 2525 (47.8) Women 15-24 1584 1395 (88.1) 1720 1488 (86.5) 1751 1345 (76.8) 2206 1691 (76.7) 2336 1786 (76.5) 2089 1277 (61.1) 25-34 1223 1066 (87.2) 1338 1163 (86.9) 1474 1154 (78.3) 1695 1260 (74.3) 1714 1212 (70.7) 1561 924 (59.2) 35-44 669 561 (83.9) 804 682 (84.8) 953 736 (77.2) 1187 889 (74.9) 1150 777 (67.6) 1223 727 (59.4) 45-54 15 11 (73.3) 116 92 (79.3) 558 441 (79.0) 689 509 (73.9) 764 520 (68.1) 825 460 (55.8) 55+ 7 1 (14.3) 11 5 (45.5) 672 516 (76.8) 798 579 (72.6) 909 684 (75.2) 970 598 (61.6) Overall participation women 3498 3034 (86.7) 3989 3430 (86.0) 5408 4192 (77.5) 6575 4928 (75.0) 6873 4979 (72.4) 6668 3986 (59.8) Overall participation

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3.1.3 HIV testing and counselling services during sero-survey rounds

During Sero3 in 1999-2000, a voluntary HTC service was provided by a trained counsellor who followed the sero-survey team, however less than 1% of study participants used the service. Since Sero4 in 2003-2004, a mobile voluntary community outreach HTC (CO-HTC)clinic has been set up within pre-existing buildings or temporary purpose constructed huts within each village, and routinely offered to all study participants. The CO-HTC service is offered for the duration of the sero-survey - i.e. for approximately one month in each village. The clinic is located close to the main sero-survey site where interview questionnaires are completed. CO-HTC services are provided according to Tanzanian national VCT guidelines (6) by trained counsellors who come from outside the study area. However, some counsellors providing HTC services during sero-surveys also provide HTC at a walk-in clinic at the study area’s main health centre (see Section 3.1.4 below). The study numbers of those using the CO-HTC service are anonymously linked to the main sero-survey questionnaire data using unique, numeric participant identifiers.

At Sero4, venous blood was collected from CO-HTC clients and transported to the NIMR laboratory in Mwanza for testing, with diagnosis based on two ELISAs as for research tests. Clients were asked to return for their test results and post-test counselling one week later, at the same location where testing had been performed. During Sero5 in 2006-2007 and Sero6 in 2010 venous blood was again collected but rapid HIV screening tests were used (preliminary test using Capillus, confirmatory test using Determine. If the preliminary test was positive and the confirmatory test was negative, the sample was sent for testing using two ELISAs as for research tests. Quality control was performed on a 5% sub-sample of rapid tests using two ELISAs as for research tests, at the NIMR laboratory in Mwanza). Where rapid HIV tests were used (i.e. from Sero5 onwards), results and post-test counselling were usually delivered to clients within 45 minutes of the test being performed.

During post-test counselling, clients with an HIV negative result were counselled about risk reduction and HIV prevention strategies, and encouraged to repeat HTC three months later for those potentially in the window period for infection, or otherwise at a later date in the future. Clients with a positive test result were advised on strategies to reduce the risk of onward transmission and on healthy living with

63 HIV. During Sero4 in 2003-2004, which was before free availability of ART in Tanzania, individuals testing HIV-positive were informed that treatment would become available in the near future through the Tanzanian national ART programme, which started at the end of 2004. With their prior agreement, these individuals were subsequently traced by the HTC counsellors and referred to an HIV care and treatment centre (CTC) at the zonal referral hospital (Bugando Medical Centre) in Mwanza city 20 kilometres away, which opened at the beginning of 2005. Individuals testing HIV-positive at Sero5 were referred for follow-up care at one of two Mwanza CTCs (either Bugando Medical Centre or Sekou Toure regional hospital), while those testing positive at Sero6 were referred directly to a local CTC which opened within the study area’s health centre at the end of 2008 (see Figure 3.2).

64 Figure 3.2 Timeline of Kisesa cohort study activities and availability of HIV services in the study area

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3.1.4 Other HIV testing and counselling services in the study area

The study population is served by a government-run health centre located in Kisesa trading centre - Kisesa Health Centre (see Figure 3.3). A voluntary walk-in HTC (WI- HTC) clinic opened at the health centre in March 2005, with services delivered free of charge and according to Tanzanian national guidelines (6), as during sero- surveys. The WI-HTC was initially based in NIMR field offices but subsequently transferred to a purpose-built clinic in June 2006. The WI-HTC includes two dedicated counselling rooms and a waiting room and is usually staffed by one or two trained counsellors dependant on financial resources, some of whom also provide the HTC services offered during sero-surveys. Rapid HIV tests are used to test finger-prick blood samples, with results usually available within 30-45 minutes of tests being performed (preliminary test using Capillus until April 2006, Bioline thereafter. Confirmatory test using Determine. A third discriminatory test (Unigold) is used in the case of discordant test results).

Between 2005 and 2008, clients testing HIV-positive at the WI-HTC clinic at Kisesa Health Centre were referred to CTCs at Mwanza city hospitals (Figure 3.2). Since the end of 2008, clients have been referred directly to the CTC located within the health centre. At this time, Kisesa residents already receiving HIV care at Mwanza city hospitals were given the option of transferring to Kisesa CTC if they were stable on ART and wished to do so. Services provided at Kisesa CTC include CD4 counts (since 2012) and prescriptions for opportunistic infections and ART, which is prescribed in accordance with Tanzanian national protocol, based on WHO guidelines.

66 Figure 3.3 Images of Kisesa Health Centre

(Images reproduced with permission from Annabelle Gourlay)

Top left: Kisesa Health Centre WI-HTC (labour and delivery ward in background). Top right: Kisesa CTC. Middle left: entrance to Kisesa WI-HTC. Middle right: WI-HTC waiting area. Bottom left: Counselling room. Bottom right: entrance to Kisesa CTC.

67 Since the roll out of a prevention of mother-to-child transmission (PMTCT) programme at Kisesa Health Centre at the end of 2008, provider-initiated testing and counselling (PITC) has been routinely offered to all pregnant women attending the health centre antenatal clinic (ANC) (Figure 3.2). Prior to this, smaller numbers of pregnant women were referred for antenatal HIV testing at the WI-HTC if they had symptoms suggestive of HIV infection, or if they requested to be tested. As part of the PMTCT programme, pre-test counselling usually takes place in a group rather than individual format, but delivery of test results and post-test counselling are conducted individually, in accordance with national guidelines (9). Pregnant women who do not wish to receive PITC may opt out, although in practice many women accept testing (141). While antenatal PITC is usually conducted at the ANC by trained nurse counsellors, women are sometimes referred to the WI-HTC, dependant on staffing and test kit availability at the ANC.

In theory PITC has been offered to patients attending out-patients clinics at Kisesa Health Centre since 2010, including a sexually transmitted infections clinic and a tuberculosis clinic. In practice the numbers of patients who have been offered these services are very small, with reported reasons for this including high patient volume resulting in lack of time to provide PITC, lack of training for clinical staff and inadequate HIV test kit supplies (Denna Michael, personal communication August 2014).

In addition to the services provided at the health centre, the population in Kisesa is served by three small dispensaries located in the rural villages of Igekemaja, Welamasonga and Ihayabuyaga. These provide basic outpatients and maternal and child health services. Since mid-2009 antenatal PITC is usually offered to pregnant women attending the rural dispensaries, dependant on the availability of test kit supplies, however HTC services for the general population are not available. Figure 3.4 and Figure 3.5 show the locations of the health facilities in Kisesa ward.

68 Figure 3.4 Map of Kisesa ward showing clinics and locations of households Clinics in Isangijo, Kanyama and Kitumba are only available temporarily during sero- survey rounds. (Map reproduced with permission from Jocelyn Poppinchalk).

Figure 3.5 Map of Kisesa ward showing mean distances to sero-survey clinics and percentage of population classified as rural.

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3.1.5 HIV prevention activities and support for HIV-positive persons in

Kisesa ward

Since the start of the Kisesa cohort study in 1994, various HIV prevention activities linked to district level HIV prevention programmes have been implemented (142). These include the establishment of village AIDS committees, school interventions and education campaigns to reduce high-risk sexual behaviour, and the provision of periodic outreach testing campaigns within villages or at community events, e.g. on World AIDS Day.

Between 2005 and 2008, a community-based organisation, TUMAINI, provided home-based care and related support services to HIV-positive persons in several wards in Mwanza Region, including Kisesa. A community volunteer was usually available to escort clients testing HIV-positive to CTC sites in Mwanza city for their first appointment, and to act as a treatment support partner for some clients. The TAZAMA project also provided a transportation allowance for HIV-positive patients travelling to attend appointments at CTC sites in Mwanza city (2,000 Tanzanian shillings or approximately £0.80 per appointment), until the CTC opened at Kisesa Health Centre at the end of 2008, when patients could access services locally.