AIDS Prevention and Treatment Program in Rural Mozambique – Executive Summary
June 29, 2006
Helen Ouyang, MPH
Harvard School of Public Health, in collaboration with the Mozambique Ministry of Health, the Real Medicine Foundation, and the African Millennium Foundation, proposes a pilot 18-month program to provide a comprehensive HIV/AIDS prevention and treatment program in rural Mozambique, for the health district of Xai Xai. A country already plagued by the aftershocks of civil war, floods, and droughts, its weak healthcare infrastructure, and in particular its shortage of healthcare workers, is currently unable to reach its geographically distant rural population.
The city of Xai Xai, located in the Gaza Province, has one of the highest rates of HIV in the country because of its location along one of the major migrant labor routes, as well as the continued marginalization of much of its rural inhabitants from the healthcare system. Considering the already greater vulnerability of women, this program will focus on targeting the wives of migrant laborers through trained female community health workers. This will rapidly and effectively expand prevention and treatment services to a marginalized population, as well as contribute to the empowerment of rural women.
While a resolution to this brain drain issue is most desired, in the meantime people living with HIV/AIDS in Mozambique need immediate access to ARV treatment. Thus, a more urgent solution is needed. Given the fact that medical doctors are so limited in the country and that those living in rural regions have virtually no access to them, it seems logical to train community healthcare workers to administer ARV treatment to these marginalized patients under strict observation, which would not only increase access to treatment but also help prevent potential drug resistance. When patients miss even a single dose of ARV medication, it becomes a significant individual and public health issue. As supported by evidence-based medicine, the public health community agrees that strict ARV compliance is one of the most fundamental means of achieving maximum effective ARV therapy in addition to curb-tailing emerging drug resistance. 
A template for this model of community healthcare workers is the Directly Observed Therapy method for tuberculosis, in particular the successful use of accompagnateurs, or community health workers, in rural Haiti, which would be transferred to the rural communities of Mozambique for HIV/AIDS. The success of the rural Haiti model of using accompagnateurs from the community itself to increase treatment adherence to TB multi-drug regimens is well-known and has been so powerful that these Haitian communities have themselves extended this model to include ARV treatment for its HIV-infected people. As an initial pilot intervention program, the HIV treatment model for this proposal will be focused on ARV therapy only.
The accompagnateurs are the structural backbone of the program. They are often well-respected members of the community and serve as the essential link between the villages and the clinic. Accompagnateurs are specially trained on the importance of confidentiality and emotional support for the patients, as well as the clinical presentation and management of HIV infection, including proper use of medications and its side effects. During daily visits to the patients’ homes, accompagnateurs are asked to directly observe the ingestion of the proper dose of the proper medications. The innovative effectiveness of the system is manifested in the “virtuous social cycle” of many accompagnateurs themselves receiving ARVs from their own accompagnateurs, which often also provides tremendous emotional support. 
In addition to treatment, the program will provide extensive education outreach programs in addition to voluntary counseling and testing, in order to encourage prevention methods. For the first time, mobile VCT services will be brought to this population, and by adopting the accompagnateur network, which has already been effective in other countries, a grassroots approach can be adapted to the specific situation in rural Mozambique, and ultimately lead to sustainable development and change. The pilot version of this program will be implemented through five continuous phases, spanning 18 months. It will be conducted in close collaboration with the MoH, those groups already on the ground in Xai Xai, and local physicians and healthcare workers.
Initially, the project will target women who are the wives of migrant laborers but will also include all consenting adult women as well. As stated earlier, this population is especially vulnerable to HIV infection, as their husbands are often traveling for long periods of time for work. This is especially important in Xai Xai, which lies along one of the major migrant labor routes in Mozambique and whose inhabitants are often migrant laborers. Because their husbands are often away for work, it will be too difficult to attempt directly observed therapy with them, at least upon initiation of the project.
By training all female community healthcare workers to target female HIV patients, this will avoid gender issues in counseling, as well as contribute to women’s empowerment in Mozambique. If the piloting of the project proves to be successful, the model can be extended to include males of the households as well, especially if their wives can help in increasing their husbands’ adherence to drug regimens. UNICEF has already been quite active in the region for the care and treatment of children affected by HIV/AIDS, as stated previously.
The purpose of the program is many-fold. It is hoped that these objectives will be met:
- To increase education and public awareness of HIV/AIDS to decrease social stigma and increase VCT.
- To provide comprehensive HIV/AIDS prevention and treatment services to those in rural areas that may not have ready access to the present healthcare system.
- To expand usage of the primary healthcare system.
- To develop a network of CHWs as one solution to the brain drain phenomenon.
- To encourage women’s empowerment and economic opportunities.
The Five-Phased Program
The keys for a successful intervention program for rural Xai Xai are the accompagnateurs, simple creative strategies to bringing the services of Day Hospitals to people’s homes, and further education to de-stigmatize HIV/AIDS. There will be five phases to the program, in addition to the initial set-up of logistics and negotiations:
Phase I: recruiting and training local physicians and community health workers.
Phase II: publicizing HIV services and education.
Phase III: mobile VCT services.
Phase IV: treatment services begin with home visits, directly observed therapy, and food/nutrition plan.
Phase V: monitoring and evaluation.
Phase I: Recruiting and training
Presently, there are two local physicians in Xai Xai who have already agreed to participate in this program. Under their guidance and leadership, with further technical assistance from experienced health workers from outside the country including ex-patriot physicians, we will recruit and train respected women of the community to be accompagnateurs. These CHWs will be responsible for education, mobile VCT services, administering treatment and food, referring patients to clinics, and social support. These women must be:
- >18 years old.
- able to devote at least six hours a day.
- able to commit at least 18 months to the program.
Preference will be given to those who have had experience with HIV/AIDS or have worked in any type of healthcare setting. They will be paid $50 a month, which is well above the average monthly income of $21,  and will also have cash incentives for meeting high performance indicators. In addition, studies have shown that non-monetary incentives may be even more influential than monetary ones in the retention and satisfaction of CHWs. These include providing CHWs with identity badges, promoting and publicizing their important role in the community, consistent communication among themselves and with their trainers, and consistently replenishing their supplies. 
Two months will be devoted to recruiting and screening applicants to train to become CHWs. During this time, the physicians and other healthcare workers will develop a training program together that incorporates local cultures and values. Coordination with the Day Hospital and laboratory facilities for CD4 counts and viral loads in Xai Xai will also take place at this time. In addition to these participants, a logistics coordinator and pharmacist will also be hired as well as two mental health specialists.
Once the CHWs have been recruited, the ITP with daily workshops will begin and span the course of six weeks. This will involve training the CHWs to provide VCT by traveling door-to-door as well as operating out of community centers. Workshops will also instruct them on visiting patients at their homes or the place of their choice, obtaining and documenting verbal informed consent, administering their HAART, keeping accurate records, education, and recognizing common signs and symptoms that require referral to health centers or the Day Hospital, including for OIs and drug toxicities. These accompagnateurs will also be trained by psychiatrists, psychologists, or mental health counselors on providing emotional support and care for patients, both during the pre- and post-test counseling as well as during the treatment phase.
In addition to this six-week ITP, the CHWs will meet with the other healthcare workers and logistics coordinator once a week for the first two months of the program, and then bi-weekly. During these meetings, refreshers on various aspects of the program will be provided and problems and other logistical issues will be addressed. In addition, this will be an ideal time and place for the accompagnateurs to provide psychosocial support for each other.
Phase II: Informing and educating the public
While the social stigma surrounding HIV/AIDS is diminishing as a result of efforts by AIDS activists and organizations such as the ICRW,  there is still much the public needs to learn about the disease. An assessment by UNAIDS in 2004 showed that only 62% of females, ages 15-24 years, are aware that a healthy-looking person can be HIV-positive, highlighting the gaps in knowledge that are obstacles to the utilization of barrier protection methods and VCT services and the obliteration of the stigmatization of the disease. 
During the time that the CHWs are being trained in Phase I, we will begin educational community outreach. We will coordinate with health workers at centers and posts to begin informing their patients that convenient VCT services will be arriving soon to their community. We will create a video that can be played at community centers and churches about HIV, aimed at de-stigmatizing the disease as well as publicizing the arrival of the new VCT services and treatment options in their community. Health messages will focus on prevention as well, including the promotion of practicing faithfulness, and using condoms. Other forms of media we will engage include: radio advertisements on the local station Radio Xai Xai  and the national Rádio Moçambique,  billboards, posters, pamphlets, fliers, lectures and speeches, and word-of-mouth. We hope to accomplish these outreach programs in collaboration with community leaders, such as heads of churches and community organizations, as well as local NGOs in Xai Xai such as the Associação para Desenvolvimento das Comunidades Rurais,  so that we can optimize reaching our target audience through culturally sensitive and effective ways. The information will be disseminated in their local Bantu language, with an extra focus on the oral communication methods, since the adult literacy rate is less than 50%.  We believe that radio will be especially effective since RM broadcasts in Portuguese and twelve Bantu languages, and most households own a radio.  Furthermore, the first community radio experiment in the country was carried out in Xai Xai in 1983, which showed that this region is quite accustomed to listening to the radio as a source of information and entertainment. 
These education programs will continue throughout the entire length of the program. They will be assessed and evaluated weekly upon initiation of the program and then monthly for the first six months, and eventually only bi-monthly. We would like these periodic assessments to take place with community leaders so they have a strong stakehold in the development and re-shaping of educational materials and media.
Phase III: VCT
Only 1.1% of the adult population received VCT services in 2003.  This is a nation-wide number, so the percentage is likely lower in rural Xai Xai, which emphasizes once again the urgency for expansion of HIV/AIDS services to the rural population. The geographical limitations prevent full coverage of the rural population by local facilities. Even with access to health posts and centers, PLWHA do not necessarily benefit because HIV/AIDS care is thus far largely limited to the Day and Provincial Hospitals. One survey conducted in Xai Xai concluded that patients usually had to walk a half hour to two hours to reach a health post, and there were no vehicular transport methods dispensed from the posts themselves. This is especially problematic considering that the health post is the most basic ground-level entry point for patients into the healthcare system. Furthermore, patients are distributed cards with their health records on them when they are finally incorporated into the system, but this can also be extremely problematic, as cards are often misplaced or lost.  Thus, it is imperative that VCT services reach out directly to any marginalized population. It is this logic that obliges us to bring mobile VCT services to this rural population.
Using Determine and Uni-Gold Tests, which produce results in about 10-15 minutes, CHWs can provide easy, rapid mobile VCT services, without losing patients to follow-up. The MoH officially uses these two tests in their VCT centers and already has an instruction manual for both tests.  A random subgroup of tests may be sent to laboratory facilities for quality assurance. Extensive pre- and post-test counseling will be provided by the CHWs, including promotion of faithfulness and condom usage, with proper instructions as well as distribution. Support and assistance with disclosure to partners will also be offered by CHWs. If necessary, CHWs can refer the patient to a psychiatrist or psychologist for further psychosocial support. We will continue to consult our two mental health counselors from Phase I who can provide this if the patient has no other access to further psychosocial services.
Women can either come to temporary VCT sites set up at community centers and churches or they can consent to a test during home visits. It is our hope that women in the community will network among themselves to advocate the use of these services. Verbal informed consent will be obtained and documented, considering the high illiteracy rate, and confidentiality will be preserved using numbers to identify the patients in records. Women can request to take a test upon the accompagnateur’s visit or upon a later time or at another place arranged with the accompagnateur when she may have more privacy. If the husband or another member of the household requests a test at the time, they may also be administered a rapid test, but will then have to be referred to the Day Hospital until treatment services can be expanded.
It is expected that each CHW will test about 3-4 patients a day, to allow time for adequate counseling, questions, and transportation. It is hoped that the CHW will provide VCT in her immediate neighborhood, so that she can travel by foot. If necessary, a CHW will be paired with a driver and vehicle. Vehicle services will be provided for CHWs when they have a patient that needs to be transported to a hospital or health facility, as well as to provide physician and mental health home visits if the patient is entirely not mobile.
The employment of the Determine and Uni-Gold Tests permit the mobile nature of VCT and will reduce the reliance on laboratory facilities. However when a patient tests positive, not only will she receive the proper counseling, but further labs will be sent off for CD4 counts and viral loads, as well as a physician check-up for OIs, HAART eligibility, and nutritional status if she is able and willing. Again, transportation will be provided by our vehicles if the women cannot arrange for transport themselves. Home visits by our physicians will be a last resort, if absolutely necessary, but we would prefer to have them enter into the primary healthcare system.
Phase IV: Treatment
The criteria used to initiate HAART in patients will be the following (see Appendix for WHO Staging System):
o WHO Stage IV disease regardless of CD4 count (if CHW has any suspicion that this may be the case, as learned through the ITP, they will refer patient to physician).
- CD4<350 cells/mm3 with WHO Stage III or IV symptoms.
- CD4<200 cells/mm3 regardless of symptoms. 
The following possible treatment regimens will be used:
D4T + 3TC + Nevirapine
AZT + 3TC + Nevirapine (for D4T toxicity)
D4T + 3TC + EFV (for Nevirapine toxicity, EFV cannot be used during pregnancy)
AZT + DDI + IND (for therapeutic failure of Regimen 1)
D4T + DDI + IND ( for therapeutic failure of Regimen 2) 
Regimen 1 will be considered optimal since it does not require prior hematological tests before initiation. Pregnancy tests will be administered before beginning Regimen 3 and hematological tests prior to initiating Regimens 2 and 4.  Pregnant women will also be referred to antenatal clinics or a midwife. CD4 counts will be performed every 6 months to determine efficacy.  Signs and symptoms for drug toxicities, which will be taught during ITP sessions, will continue to be monitored by the accompagnateurs, with referral to Day Hospitals or other health facilities if necessary.
Estimating that 25% of the PLWHA will be HAART-eligible,  it is anticipated that out of the 4,188 PLWHA in Xai Xai, with about 108 already on ARV therapy and 57% adults affected being women,  ,  there will be about 550 HAART-eligible women in Xai Xai. It is hoped that we can find and consent 350 women to therapy, which would require about 40 CHWs.
Since one or more drugs in these regimens require twice-daily dosing,  the CHWs will visit the patients’ homes twice daily for the initial three months. If the patient and the CHWs feel comfortable, this will be tapered to a morning visit, with the patient taking the second dosage of medicine on her own in the evening, which proved to be effective in resource-limited settings in both San Francisco and Los Angeles county.  , 
In addition to treatment, monitoring for drug toxicities and OIs, and psychosocial support, the CHWs will be responsible for ensuring that the nutritional status of the patients is sufficient. If it is not or there is doubt, the program will also supply meals and supplements to the patient, through the WFP. A nutritionist, in the category of other healthcare workers, will serve in a consultant’s capacity in the program.
To provide the proper psychosocial support and for the purposes of continuity, the CHW that provided the VCT for a patient will also continue on for her treatment phase as well, if necessary. If an accompagnateur feels overwhelmed based on quantity of patients, other accompagnateurs in the closest geographical proximity can take over their patients, preferably early on in the treatment phase. For adequate time and support, each accompagnateurs should be responsible for about 10-12 patients which may increase in number, as the patients who have been in the program longer need less time.
Phase V: Monitoring and Evaluation
Once the program is initiated, there are several indicators that should be monitored, with respect to the patients and the CHWs. Every 6 months, CD4 counts, viral loads, and weight changes will be assessed. The target is to have by the end of 12 months of treatment:
- 95% treatment adherence.
- 80% undetectable viral loads.
- Increase in CD4 counts by 150 cells/mm3.
- 5 kg weight gain.
- Improvement of symptoms by the end of 12 months.
In addition, the increase in number of patients entering the primary healthcare system should also be monitored.
The CHWs will be evaluated by the number of patients they capture in VCT and percentage retention of patients on treatment programs. In addition, surveys of patients assessing their HIV knowledge may also be performed. Monetary incentives will be given for meeting absolute goals, not relative to each other, to encourage camaraderie.
It should be emphasized that these five phases are not mutually exclusive nor segmental; the program will provide training, education, testing/counseling, treatment, and monitoring on a continuous basis.
As with any program of this scale, there may be limiting factors. The first is that despite the best education and public health efforts, social stigma may prevent patients from participating in VCT or the treatment program. Secondly, drop-out may occur for various reasons, including drug intolerance, fear of stigma, lack of privacy, partner discouragement, logistics and time, irresponsibility, among others. Drop-out could also result in the increase in ARV resistance in the community. Another problem may be that such a rural healthcare system may not be ready for such a scale-up of HIV/AIDS care; laboratory services, for example, may not be able to turn over results at an adequate pace. Clinics and centers may not be able to handle a greater influx of patients, and even if they can, patients may still not be able to easily access them even with our transportation provision efforts. Pregnant women may still not be able to easily travel to ANCs or connect with midwives, in which case we can only provide antenatal vitamins and pMTCT prophylaxis. In addition, a key limitation of the program, at least upon its initial inception, is that males and children will be excluded. UNICEF is already providing many services for children, and it is hoped that if the program is successful, we can include men as well, though not initially because many of them are migrant workers and thus their erratic presence complicates any kind of DOT program. Finally, sustainability is always an issue, in terms of financial resources and human capital. Every effort will be made to seek commitments for further funding for at least the next 5 years and to maintain satisfaction among the accompagnateurs.
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